Pai Pharma Jobs in Usa

Job Title: Systems Engineer

Location: Oro Valley, AZ (Onsite)

Duration: 18-Month Contract

About the Role

Seeking a motivated, hands-on Systems Engineer to support a new Project, focused on advancing cancer diagnostics through state-of-the-art testing automation. This role plays a critical part in defining product requirements, system architectures, and risk management strategies for in-vitro diagnostic (IVD) solutions used globally across more than 250 cancer tests and associated instruments.

This is an onsite position ideal for an engineer with strong electro-mechanical systems experience and a background in regulated medical device development.

Key Responsibilities

• Apply Systems Engineering principles across the product lifecycle, including requirements definition, system architecture, risk analysis, and verification & validation
• Manage front-end systems engineering deliverables related to requirements, risks, trade studies, and testing
• Plan and execute requirements management, risk analysis, and V&V activities
• Analyze complex technical problems, develop solution options, and support data-driven decision-making
• Conduct industry and technology assessments, including emerging trends and competitive product analysis
• Collaborate cross-functionally with R&D, Marketing, Operations, Quality, and Regulatory teams
• Engage with business stakeholders and Voice-of-Customer (VoC) representatives to align technical solutions with customer needs

Required Qualifications

• Experience in front-end Systems Engineering, including requirements engineering, architecture definition, risk management, and trade-off analysis
• Hands-on experience with systems and hardware integration and testing
• Experience working in a regulated medical device environment
• Familiarity with FDA, ISO, and other applicable diagnostic product standards
• Experience using systems engineering tools such as RETINA or similar platforms

Preferred Qualifications

• Deep knowledge of reliability, manufacturability, and usability engineering
• Strong leadership presence with the ability to build authority and accountability within cross-functional teams
• Excellent communication, collaboration, and stakeholder-management skills
• Strong organizational skills with the ability to prioritize and manage multiple workstreams effectively

#Verification #Validation #RETINA #Diagnostics #pharma #pharmaceutical #lifescience #medicaldevice #IBMDOORS OR #DOORSNext #JamaConnect #Polarion #WindchillRV&S #PTCIntegrity #HPALM #QualityCenter #INCOSE #requirementsengineering #requirementsgathering #requirementsmanagement

Position Title: Sr. Program / Portfolio Manager

Duration: 12+ Months

Location: Alameda, CA

Job Description:

We are seeking a strategic and experienced Senior Program & Portfolio Manager with a strong background in the Pharmaceutical/Life Sciences industry to lead cross-functional teams across various geographic locations. The Program Manager will be responsible for the product portfolio, maintaining overarching plans, and managing cross-product interdependencies. This role requires strong collaboration and the capability to govern and support the ways of working across the portfolio of products. The ideal candidate will have extensive experience in managing large programs / portfolios as well as excellent lean program management skills.

The Program Manager will be the primary point of contact for the client and is responsible for the overall engagement and program success. The program manager is responsible for facilitating client feedback on deliverable quality, strategy, and performance to responsible company department resources and initial point of contact for escalations that may arise.

Key Responsibilities:

Strategic Leadership

• Drive portfolio governance and ensure alignment with corporate objectives.
• Understands client's priorities in order to develop, manage, and continually refine the initiatives' schedules across the program
• Lead product development programs in the pharmaceutical industry.
• Champion agile transformation and continuous improvement across delivery teams.
• Lead business process development and optimization, with a focus on functional products and portfolio management capabilities

Portfolio / Product Execution

• Responsible for cross initiatives plan development, scope management, adherence to budget and timelines, and product change control
• Manage documentation, including charters, status reports, and post-initiative evaluations

Stakeholder Engagement

• Communicate, Collaborate, and Align with the cross-functional teams to identify, map, and track cross-functional dependencies impacting delivery and timelines
• Capability to drive cross-product initiatives communications, highlight dependencies across workstreams
• Coordinate with cross-product initiatives teams to ensure milestones are met
• Monitor progress and provide regular updates to stakeholders
• Conduct status calls on a regular cadence to ensure progress to schedule

Compliance and Risk Management

• Collaborate with client resources and Company resources to drive product delivery, identifying any risks and obstacles and clearly communicate and track action items
• Support client leadership to establish, maintain and lead high performance product teams
• Provide portfolio / program management oversight to assigned consultants, as needed
• Complete activities that promote professional development, including involvement in professional organizations and leading internal initiatives.
• Responsible for functional workstream planning and dependency management, delivery management for downstream consumption, issue and risk management, drive SIT and UAT, drive documentation for release and roll out
• Ability to address and resolve blockers

Process Excellence

• Help advance product mindset by embracing client tools and relevant processes
• Promote operational excellence with workflow automation, licensing strategy for agile management products, devise operational dashboards, provide insights, best practices and templates
• Develop workflow standardization across initiatives, sub product mappings and integration rollout and documentation

Required Qualifications

• 15+ years' experience in program and product management, preferably in a cross-functional or matrixed environment
• 3-5 years of experience in Life Sciences / Pharma industry
• Bachelor's degree in business, program/product management, operations, or a related field or equivalent work experience
• Proven ability to manage complex portfolios and coordinate multiple teams.
• Experience in collaborating across Corporate Departments including business and IT
• Strong organizational and analytical skills.
• Excellent communication and senior stakeholder management capabilities.

Preferred Qualifications

• Certifications: PMP, PgMP, PMI-ACP, SAFe® Agilist, CSM, Lean Six Sigma, or equivalent program management experience.
• Experience or certification in GxP, GAMP® 5, or regulatory affairs (RAC) is a strong plus
• Ability to manage complex portfolios & coordinate multiple teams simultaneously
• Proficiency in tools such as Aha!, JIRA, Confluence, and Smartsheet.
• Experience in risk management
• Ability to take the initiative and propose new ideas / ways of working
• Working experience with product management and Agile framework, methodology and tools
• Ability to influence without authority and resolve conflicts.

The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.

I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Discover Veranova

At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference.

Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. 

Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. 

Role Overview:

Core Responsibilities:                                                                                                                   

• 
  
• Environmental Program Management: Lead, implement, and continuously improve environmental programs that align with local, state, and federal environmental regulations and Veranova’s sustainability goals. Manage waste management, water conservation, air emission controls and data emission logging, energy efficiency, and emissions control programs.
  
• Regulatory Compliance & Reporting: Ensure compliance with environmental regulations and company policies. Prepare and submit environmental reports and documentation to regulatory agencies as required. Support audits and inspections by regulatory bodies. Manage site compliance calendar (legal register)
  
• Environmental Risk Assessment: Conduct environmental impact assessments and identify potential environmental risks associated with site operations. Recommend strategies to mitigate negative environmental impacts and ensure compliance with environmental laws, including site expansion and construction projects.
  
• Sustainability Initiatives: Lead site sustainability committee, collaborate with internal and global teams to drive sustainability projects focused on reducing the site’s carbon footprint, improving energy usage, reducing waste, and enhancing recycling efforts. Continue involvement with Devens Enterprise Commission on sustainability and volunteer programs.
  
• Training and Education: Develop and deliver environmental training programs to employees to ensure they understand environmental policies and best practices. Foster a culture of environmental awareness and responsibility across the site.
  
• Waste Management: Oversee the safe and compliant management of hazardous and non-hazardous waste, ensuring proper disposal and documentation according to environmental regulations.
  
• Environmental Impact Reporting & Continuous Improvement: Track and analyze environmental performance metrics, providing recommendations for improvement. Drive continuous improvement initiatives related to environmental management practices.
  
• Emergency Response & Environmental Incident Management: Assist in the development of emergency response plans for environmental incidents, such as spills or accidental releases. Provide support in managing and investigating environmental incidents when they occur.
  
• Cross-functional Collaboration: Work with other departments (e.g., manufacturing, production, facilities) to implement environmentally friendly practices and ensure adherence to environmental guidelines in daily operations.
  
• Safety Programs: Support of OSHA safety programs, including incident management, root cause investigation and emergency spill response.
  

Qualifications: 

Required

• 
  
• Bachelor’s degree in Environmental Science, Environmental Engineering, or a related field
  
• Minimum of 2 years' experience in environmental management, with a strong understanding of environmental regulations, risk assessments, and sustainability practices
  
• Work in a collaborative manner as well as the ability to work independently and in a team environment across multiple functions and sites
  
• Strong drive for results including taking the initiative
  
• Good time management skills and adaptability to new and changing circumstances
  
• Self-motivated learner with demonstrated ability to exercise good judgment and make decisions quickly
  
• Good written and verbal communication skills
  
• Experience communicating effectively to management
  
• Willingness to perform other duties as assigned
  

Preferred

• 
  
• Professional certifications
  
• Experience in pharmaceutical or chemical industries
  

Special Factors 

• 
  
• Ability for overnight travel, up to 15%
  
• Ability to work in a chemical manufacturing plant
  
• Primarily a site-based role
  
• Potential international travel to United Kingdom
  

Salary Range: $105,000 - $115,000 annual base salary

Our Commitment:

• 
  
• Health & Wellness: Comprehensive health & Wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. 
  
• Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs.
  
• Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
  
• Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We are committed to ensuring that everyone can bring their full self to work and thrive in their career.
  

How to Apply: 

At Veranova, we are on a mission to meet people that believe in our values and can contribute to the team in a variety of ways. Please visit to view all open roles and join our Talent Community to stay connected and learn about opportunities as they arise. 

We value a range of experiences and perspectives. If you want to be part of improving and saving the lives of patients, we encourage you to apply regardless of whether you meet every qualification listed. 

Additional Information:

Applicants for this role must be authorized to work in the United States without further employer sponsorship.  

Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. 

All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law.

All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.

Packaging Mechanic (2nd Shift)

$32 – $37/hour + 10% shift differential

Pharma Manufacturing | Bethlehem, PA

6-month Contract (Solid potential to be hired on if you possess strong electrical skills)

Are you an experienced Packaging Mechanic with a passion for pharmaceutical manufacturing? We’re seeking a dedicated Packaging Mechanic to ensure our state-of-the-art facility runs smoothly and efficiently. This is an excellent opportunity to grow your career with a fast-growing company dedicated to innovation and quality.

Key Responsibilities:

• Perform preventive maintenance on advanced packaging equipment to minimize downtime and ensure optimal performance.
• Set up, calibrate, and execute changeovers of packaging machinery to meet production schedules.
• Monitor and analyze machinery operation, quickly identifying and resolving issues to maintain continuous production.
• Maintain equipment in compliance with cGMP (current Good Manufacturing Practices) to ensure product quality and regulatory adherence.
• Troubleshoot and repair vision systems, serialization units, barcode readers, and PLC-controlled machinery.
• Collaborate closely with Engineering teams to install, optimize, and upgrade packaging systems.
• Maintain detailed documentation of maintenance activities and equipment qualification status.

Qualifications:

• Previous experience with packaging lines preferred; cGMP experience is a plus.
• Strong mechanical aptitude with excellent troubleshooting skills.
• Proficiency with PLCs, HMIs, pneumatics, and electromechanical systems.
• Knowledge of serialization and barcode systems.
• Demonstrated experience working with servo and PLC-driven machinery.
• Pharmaceutical manufacturing experience (2+ years) is advantageous.
• Forklift operation experience preferred.

Why Join Us?

• Opportunity to work with cutting-edge pharmaceutical technology in a modern facility.
• Competitive pay rate with available overtime to boost earnings.
• Potential for permanent placement based on performance.
• Gain valuable experience in a regulated cGMP environment.
• Supportive team environment with a focus on safety, quality, and continuous improvement.
• Clear pathways for career advancement and skill development within a growing industry.

If you’re detail-oriented, proactive, and eager to contribute to a dynamic manufacturing environment, we want to hear from you! Apply today to join a company committed to excellence and innovation in pharmaceutical packaging.

Why Us?

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.

The Strategic Sourcing Manager-Indirect will be responsible for designing, managing and implementing sourcing strategies for the enterprise. This role will work closely with various business owners and functional leadership throughout the enterprise and will be responsible for delivering category management services including but not limited to, strategic sourcing, client stakeholder management, supplier performance management and continuous cost and performance improvement. In addition, this person will collaborate closely with the FP&A team to coordinate annual cost reduction targets rolling up to an annual cost target for the enterprise. The ideal candidate must possess a high level of interpersonal, communication, analytic, legal acumen, and financial skills to promote positive working relationships with business partners and suppliers to create long-term value for the enterprise within the highest standards of the industry and in compliance with the law. The role will establish effective ongoing relationships with key business partners to ensure sourcing is effectively integrated into the strategy of the business and involved in all purchasing decisions. Competency in project management to drive a fact-based approach to deliver on commitments. The role must have a working knowledge of Procurement and Strategic Sourcing Systems (i.e. Coupa, SAP, JDE, CLMs, etc), category management techniques, 7-step sourcing process, supplier management, strong legal acumen in negotiating service and supply agreements, and spend analytics.

Scope of Authority

• Company-wide indirect spend focused on IT, Corporate Services, Legal Services, Logistics, and Finance related categories along with others as assigned.

ESSENTAIL FUNCTIONS:

Key Accountabilities:

Strategic Sourcing / Procurement = 70%

• Design and implement cost savings/value driving projects across multiple indirect sourcing categories based on historical and forecasted spend.
• Establish annual savings targets with Business Partners in support of business goals.
• Research and collaborate with internal stakeholders and external resources to identify a broad selection (e.g., large, boutique, small, diverse) of qualified suppliers to participate in sourcing events and other projects.
• Evaluate competitive offerings to determine the overall best offer for a service or product. Manage the analysis of proposals in support of the bid evaluation process.
• Skillfully apply appropriate procurement approach in negotiations. Prepare and lead negotiations to conclusion.
• Review and assess current supplier contractual terms and conditions to determine strategic direction and negotiation strategies. Work closely with Legal, Compliance and Finance organizations on drafting and executing final agreements for services and/or products.
• Manage risks and protect Company intellectual property.
• Ensure compliance with purchasing policies and procedures, ethical practices and adherence to relevant laws and regulations.
• Manage and resolve contract differences with suppliers.
• Identify cost reduction, cost avoidance, and cost containment opportunities.
• Analyze category market conditions, customer requirements, pricing trends and competitive benchmarking to determine appropriate sourcing strategy. Utilize relevant Company procurement and contract systems.

• Supplier & Contract Management & Reporting = 20%
• Develop internal and external relationships with suppliers and cross-functional teams regarding the following:
• Evaluate supplier performance data to eliminate or mitigate supply chain constraints or risks. Drive supplier innovation to remain competitive.
• Support reviewing supplier demonstrations with functional management and end-user departments.
• Coordinate supplier visits and evaluations to determine suitability.
• Assist in developing supplier performance measurements using rating systems or predetermined standards.
• Develop and drive effective relationships with suppliers.
• Coordinate, review and respond to supplier inquiries, protests and appeals.
• Develop and execute Supplier Diversity reporting and data analytics for internal and external reporting as required.

• Stakeholder Relationship Management = 20%
• Work closely with key stakeholders to:
• Understand priorities.
• Develop with and agree upon sourcing strategies / plans and set expectations for effective value delivery.
• Help the stakeholder understand Company’s procurement requirements, so they proactively engage Procurement.
• Develop high value strategies that align with overall enterprise goals for quality, service, and cost.

MINIMUM REQUIREMENTS:

Education:

Undergraduate degree in Business Administration, Finance, Management, Supply Chain Management, life sciences, or technical field – MBA preferred

Experience

• Minimum seven to ten years’ experience in strategic sourcing/purchasing (preferably in the pharmaceutical industry), including the use of sourcing technologies (i.e. Coupa, Corcentric, etc) to develop and conduct RFIs and RFPs, with exposure and responsibility for various functional areas (supplier management, spend analytics, contracting, negotiating, bid management).
• Minimum 5+ years’ experience in souring IT goods and services.
• Four to six years in a position leading cross-functional teams in the development of sourcing or supplier management strategies for key indirect expenditure categories (e.g., IT, Finance, Sales and Marketing, Legal, Facilities, MRO, HR, R&D, Professional Services, Capital Projects).
• One to three years’ experience consulting with C-level and/or functional vice presidents and directors of business units to influence corporate decision making related to purchasing.
• Experience structuring, negotiating and managing service and supply agreements with suppliers including, but not limited to complex long-term strategic agreements, short-term transactional agreements and project-based or consulting agreements.

Knowledge

• Knowledge of various categories of indirect spend in the Pharma Industry.
• Strategic Sourcing Methodology (7-step)
• Strong financial skills
• Strong legal acumen
• Working knowledge and skills with ERP systems, Procurement and Strategic Sourcing Systems, MS Excel, MS Word, MS Power Point, and MS Project.
• Understanding business implications of decisions; Displays orientation to profitability.
• Demonstrated knowledge of market and competition.
• Understanding of supplier diversity reporting methodologies and best practices.
• Strong communication skills and ability to work effectively with a variety of stakeholder types (e.g. Local Supply Chain, Executive Leadership).

Skills & Abilities

• Ability to use a variety of tactics (e.g. research, analysis and networking) to identify opportunities.
• Exceptional interpersonal skills, with ability to influence decision-making and drive positive outcomes.
• Ability to independently evaluate, assess and initiate actions.
• Ability to develop and deliver compelling presentations.
• Excellent verbal and written communication skills.
• Experience managing data analysis and/or developing reports.

RELATIONSHIP WITH OTHERS/ SCOPE:

• Internal Contacts – no direct reports. Will interact with senior leaders to include Directors, VP, and C-suite level IT, Ops, Finance, and Commercial executives.
• External Contacts – VP level vendors and suppliers.

WORKING CONDITIONS:

• Position will work both an office environment and in a manufacturing plant environment.
• Must be able to wear the required Personal Protective Equipment (PPE) out on the plant site as deemed necessary by EH&S.
• Hybrid position based out of Hazelwood MO.
• Occasional travel required conference vendor sites.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

EEO Statement:

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Immediate need for a talented Quality Specialist - II (Associate). This is a 06+months contract opportunity with long-term potential and is located in Wilson, NC, (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 26-08239

Pay Range: $45/hr - $45.86/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Support for the Global Enterprise Asset Management System (EAMS) Project, including:
• Migration of data from legacy data to new system
• Support of required project documentation
• Support the Quality IPT with other activities including:
• Batch record documentation and/or audit
• CoA/CoC generation and review
• Data review and updates
• Additional responsibilities may be assigned as needed
• Attends team meetings and any required cross-functional meeting to ensure alignment of priorities and escalation of obstacles

Key Requirements and Technology Experience:

• Key skills; “Batch record”, QA, Pharma
• Bachelor's degree preferred. Candidates with Associates degree considered with relevant experience.
• 3-5years of relevant experience within a GMP pharmaceutical manufacturing facility with direct involvement in execution of activities such as batch record, documentation reviews, investigations, corrective actions, complaints, quality system management, quality assurance, quality control, investigation etc.
• Experience in Quality Assurance.
• Experience working in a pharmaceutical packaging facility.
• SAP, maintenance system, and/or SOP experience.
• The candidate must possess highly developed written and oral communication skills.
• The candidate must also possess a high degree of problem-solving ability and have demonstrated ability to independently manage multiple projects/workload, ensuring timely completion.

Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.

Immediate need for a talented Compliance Specialist II (Manufacturing/Quality). This is a 12 Months contract opportunity with long-term potential and is located in Northborough, MA , USA(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job Diva ID: 26-08294

Pay Range: $33 - $43/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Support department Quality Management System (Change Control, Deviations, CAPA)
• Main Accountabilities- Ensuring that activities within scope are conducted in compliance with applicable regulatory requirements
• Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations
• Perform finished product inspections according to standards, specifications established timelines
• Perform AQL inspections according to standards, specifications established timelines
• Trend AQL failures according to standards, specifications established timelines
• Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)
• Manage the sampling, storing, monitoring and maintenance of finished product retention samples according to standards, specifications and established procedures and timelines
• Manage / perform annual inspection of retention samples
• Support creation of new material and product specifications
• Perform document creation/revision, including periodic reviews, for department documentation according to established procedures and scheduled timelines
• Support department Quality Management System (Change Control, Deviations, CAPA)
• Support department documentation archival system
• Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor
• Managing / escalating and resolving quality-related issues in a timely and effective manner
• Support the monitoring and analyzing of quality performance metrics, implementing corrective actions as needed
• Support root cause analysis investigations for quality incidents and implementing preventive measures
• Support quality walkthroughs
• Participating in internal and external audits and regulatory inspections providing support and documentation, as well as speaking as a subject matter expert in area of focus
• Support risk management strategies to mitigate potential quality issues
• Fostering a culture of quality and continuous improvement across the organization
• Request corrections when GMP rules are not respected
• Prioritize quality and compliance objectives
• Request quality improvement initiatives and strategies
• Identify discrepancies and corrective/preventive actions that need to be taken
• Escalate to upper management any failure in GMP execution on shopfloor
• Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures
• Advise on how to present a topic and answer specific questions
• Advise on risk management strategies and plans
• Advise on initiatives to promote a quality-focused culture

Key Requirements and Technology Experience:

• Key skills: - Experience with inspecting finished goods and product
• Quality Shop floor experience
• Fully onsite position Possibility of extension Open to candidates willing to relocate at their own expense
• Top candidates, references will be requested Free parking onsite
• Bachelors degree (Masters and PHD's will be accepted)
• 3 Year experience in related role (more experience the better)
• Quality Shop floor experience, quality assurance review experience
• Experience with inspecting finished goods and product
• Previous pharma and biotech experience / GMP (strongly preferred)
• Change Control, Deviations, CAPA (strongly preferred) • SAP, Veeva
• Minimum 3 years of related experience
• Minimum Education: Bachelors degree

Our client is a leading Pharmaceuticals industry , and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

By applying to our jobs, you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.

Astek is strengthening its teams of QA Specialists.

Description :

Quality Assurance for Clinical Supply & Cold Chain, supporting the review and approval of GDP documentation generated in the context of supplying products for clinical studies.

Main tasks :

• Review of Supply Flow in line with clinical logistics strategy and qualified status of providers used
• Review of feasibility analysis of transfers between commercial sites, technical research and development GMP department, and its CMOs or between clinical sites to ensure quality attributes of products received and compliance of providers used
• Generation and/or review of cold chain documentation provided to CMOs/CROs to confirm storage conditions and cold chain budget allocated to CMO/CRO activities
• Determination of the cold chain budget available at the time of Release of batches prior to shipment to clinical sites
• Assessment of temperature excursions during storage or distribution of products for clinical studies

Required skills :

• 3 to 5 years of experience in a Quality Assurance environment; ideally in the pharma industry
• Knowledge of cGMP, GDP, cold chain, manufacturing operations, clinical trial, product development and regulatory requirements
• Need of a good scientific background to understand the objectives of the studies and to interact with both GMP & Clinical operations
• Understanding of how clinical trials are set up and run as well as the associated legal and regulatory framework
• Good communication skills: ability to listen effectively, communicate complex matters both verbally and in writing, and ask questions that lead to the discovery of root causes
• Master's degree in Sciences/Engineering/Bioengineering

Clinical Trial Associate - HYBRID in Wilmington, DE

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

What You Will Be Doing:

• Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
• Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
• Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
• Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.
• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”
• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
• Contributes to the production and maintenance of study documents, ensuring template and version compliance.
• Creates and/or imports clinical-regulatory documents into the Global Electronic Management System
• Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.

Your Profile:

• Industry experience in clinical trial support required (CRO/Pharma)
• BS/BA degree required
• Experience with vendor management, strong verbal & written communication skills,
• and strong organizational skills
• Previous administrative experience
• Proven organizational and administrative skills
• Computer proficiency
• Display excellent organization and time management skills, excellent attention to
• detail, and ability to multi-task in a high-volume environment with shifting priorities
• Team oriented and flexible; ability to respond quickly to shifting demands and
• opportunities
• Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to study Start-up, together with an understanding of the ICH/GCP guidelines
• Ability to develop advanced computer skills to increase efficiency in day-to-day tasks
• Good interpersonal skills and ability to work in an international team environment
• Willingness and ability to train others on study administration procedures
• Integrity and high ethical standards
• eTMF experience in Veeva required
• Must be comfortable with a home/office-based hybrid role in Wilmington DE.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Program, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

Location: Upstate NY (Relocation from Canada welcome!)

Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.

ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

This is an outstanding opportunity to join our growing team!

Full-Time | Onsite

About the Role:

We’re looking for a detail-driven HEPA Certification Coordinator to manage and maintain HEPA filter compliance across our pharmaceutical cleanroom facilities. You’ll work with internal teams and external vendors to ensure air quality standards are met and documented.

What You’ll Do:

• Oversee HEPA filter certification and scheduling
• Ensure compliance with GxP and industry standards
• Coordinate with vendors and internal teams
• Maintain accurate documentation and reports
• Support investigations and continuous improvement

What You Bring:

• 3+ years in pharma manufacturing with cleanroom experience
• Knowledge of HEPA standards, GxP
• Strong communication and organizational skills
• Bachelor’s in engineering, Science, or related field

Perks & Benefits:

• Competitive salary
• Full health, dental, vision, and retirement benefits
• Tuition reimbursement, PTO, and more

Ready to make an impact? Apply now and help us maintain the highest standards in cleanroom air quality.