First Quality Tissue Jobs in Usa

Overview

A leading biotechnology organisation is seeking an experienced Executive Director, Clinical Quality Assurance to provide strategic leadership across clinical quality operations. This role is responsible for ensuring compliance with global regulatory standards (GCP, GVP, GLP) while driving continuous improvement in clinical quality practices.

Working closely with senior leaders across Quality, Discovery, and Development, you will shape and execute global and regional quality strategies aligned with pipeline objectives. This position plays a critical role in setting the vision, standards, and long-term direction of the Clinical Quality Assurance function.

Responsibilities

• Lead the development and execution of clinical quality assurance strategies, ensuring compliance with global regulations and industry standards
• Establish and maintain robust quality systems, including SOPs, policies, and quality documentation
• Drive continuous improvement initiatives to enhance quality, efficiency, and compliance across clinical operations
• Develop and implement risk management frameworks to identify, assess, and mitigate clinical risks
• Define and monitor key quality metrics and KPIs, providing regular updates to senior leadership
• Collaborate cross-functionally with clinical operations, regulatory, pharmacovigilance, and other teams to ensure alignment
• Build and lead a high-performing Clinical Quality Assurance team to support the clinical development portfolio
• Oversee vendor qualification, audit programmes, and ongoing compliance for external partners (e.g., laboratories, CMOs, depots)
• Develop and manage audit strategies for clinical sites and vendors
• Lead preparation and management of regulatory inspections, acting as the primary point of contact for health authorities
• Support training, inspection readiness, and remediation activities as required
• Promote a strong culture of quality and compliance across the organisation

Requirements

• Bachelor’s degree in a scientific discipline (advanced degree preferred)
• +10 years experience in GCP Quality roles
• Proven experience in both strategic and operational clinical quality assurance
• Strong understanding of GCP, GLP, GVP, and broader GxP requirements
• In-depth knowledge of regulatory requirements across multiple regions (e.g., US and EU)
• Excellent communication and stakeholder management skills

Quality Systems Director – Permanent – New York

Proclinical is seeking a Quality Systems Director for an emerging biotech company based in New York.

Primary Responsibilities:

In this role, you will be responsible for the hands-on oversight of all Quality Assurance (QA) Good Manufacturing Practices (GMP) activities pertaining to the manufacture of drug product, analytical, packaging, labeling, distribution, and release of Clinical Supplies. You will own and lead the CMC Quality function across internal operations and external partners (CMOs/CROs/contract laboratories), including batch disposition, quality systems, change management, deviations, investigations, complaints, audits, and product release activities.

The position is based onsite in New York.

Skills & Requirements:

• B.S. or B.A. or higher degree (preferably in Life Science) with 10+ years of hands-on experience with increasing responsibility as a Quality Assurance Professional.
• Experience in small molecule development, batch release, and SOP drafting.
• Hands on experience implementing quality management systems in a GxP environment, and direct experience with FDA and other health authority inspections.
• Strong understanding and extensive knowledge of industry practices and global regulatory requirements (FDA, EMA, ICH) for clinical-stage products.
• Proven ability to build or scale quality systems in a dynamic environment.
• Prior experience managing CDMOs and external quality oversight strongly preferred.
• Experience in supporting IND/CTA/IMPD submissions and clinical supply release preferred.

The Quality Systems Director will:

• Author, review and approve Standard Operating Procedures (SOPs), protocols, reports, specifications and other quality records for accuracy and compliance with all applicable regulations, guidance, and international standards.
• Review and provide quality input for CMC sections of product registration applications, and Investigational Medicinal Product Dossier (IMPD) submissions for drug substance, drug products analytical methods and stability studies.
• Develop and execute the CMC QA strategy aligned with company goals and regulatory expectations.
• Build, refine, and scale quality systems appropriate for a fast-growing biotech (e.g., change control, deviations, CAPA, document control, supplier management).
• Serve as the primary QA point of contact for CMC, manufacturing, analytical development, supply chain, and regulatory teams.
• Build and oversee cGMP Quality Management Systems, Batch Review and Release, Quality Control testing activities and disposition of packaging products to ensure compliance with internal procedures and global regulatory requirements (e.g., FDA, EMA, ICH).Manage quality audits at CMOs, CROs, contract labs including the implementation and monitoring of audit related corrective and preventative actions (CAPAs).
• Lead and facilitate thorough cGMP investigations for process deviations, out of specification test results, Out of Tolerance, and Out of Specifications events and identify root cause and CAPAs. Provide Quality Assurance input for failure analysis, problem solving, and risk assessment and mitigation activities related to the qualification and validation of the cGMP facility and equipment.

If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at ( or .

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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.

Work Location: NY/NJ

Work Setting: Hybrid

About NSIPA:

Network Solutions IPA (NSIPA) is a leading New York–based Independent Practice Association with a diverse, multi-specialty provider network. The organization has grown to more than 600 physician members, serving over 100,000 patients across New York City, Nassau, Suffolk, and Westchester counties.

We are committed to helping independent providers succeed in the transition to value-based care.​

Through strategic partnerships, operational support, and robust payer relationships, NSIPA delivers the tools, resources, and expertise that allow practices to grow, perform, and succeed in today’s complex healthcare landscape without sacrificing independence. ​ We achieve this by collaborating with payers to deliver Quality Incentive Programs, Shared Savings arrangements, and Risk-Based Contracts. Contracted with over 21+ Payers for over 600+ Providers.  

NSIPA provides a comprehensive suite of services, including credentialing and network operations, provider engagement, and contracting; care coordination and member outreach; and provider-and patient centered programs. As part of New York State’s 1115 Medicaid Waiver, NSIPA plays a key role in identifying, screening, and addressing health-related social needs by connecting Medicaid members to community-based resources and care supports. These services are designed to strengthen provider efficiency, address health related social care needs, and advance value‑based care and population health opportunities. Recognized as one of New York’s fastest‑growing IPAs, NSIPA supports improved clinical outcomes, enhanced provider performance, and cost savings for payers through its robust infrastructure and operational expertise.

Position Overview:

We are seeking an experienced leader to oversee NSIPA’s value-based care strategy and quality performance across all payer contracts. This role is responsible for improving clinical quality, utilization, and financial outcomes while driving population health initiatives and ensuring strong performance under value-based and risk-based arrangements.

The Director will lead the Population Health Quality team and collaborate with executive leadership, providers, payers, and cross‑functional teams to drive measurable improvements in cost, quality, and care delivery. This is an ideal opportunity for a seasoned leader who thrives in complex, multi‑payer environments and is passionate about improving care for Medicare, Medicaid, and managed care populations.

Roles & Responsibilities:

·        Own NSIPA’s value-based care and quality improvement strategy across all payer programs.

·        Oversee performance related to MER, total cost of care, utilization, and quality outcomes.

·        Partner with executive leadership and cross-functional teams to identify performance risks, opportunities, and intervention strategies.

·        Lead quality programs including HEDIS, QARR, CAHPS measures, medication adherence and transitions of care.

·        Develop and execute performance improvements and corrective action plans.

·        Oversee performance monitoring and improvement initiatives related to quality, utilization, and total cost of care metrics.

·        Collaborate with Provider Engagement to support underperforming providers and ensure documentation and quality standards are met.

·        Partner with Data & Analytics to turn complex claims, EHR, and payer data into actionable insights.

·        Build and guide a high-performing Population Health Quality team.

·        Provide oversight of the Peer Review Committee (PRC), including case review, provider communication, documentation, and reporting.

·        Serve as a key liaison with payer partners on VBC performance, quality initiatives, and contractual requirements.

·        Ensure compliance with regulatory, audit, and accreditation standards.

·        Support performance strategies under risk-based, shared savings, and value-based arrangements.

·        Responsible for developing educational materials and resources, including content, brochures, and one-pagers, centered on quality and value-based care (VBC) initiatives to support provider and staff education and performance improvement efforts.

Skills & Competencies:

·        Strong understanding of value-based care, population health, and risk arrangements.

·        Expertise in quality measurement (HEDIS, QARR, CAHPS, CMS).

·        Advanced analytical skills with the ability to interpret and act on complex data.

·        Strong leadership, communication, and cross-functional collaboration skills.

·        Ability to manage multiple priorities in a fast-paced environment.

·        Proficiency in MS Office, experience with data visualization tools (Tableau) or similar tools preferred.

Required Qualifications:

·        Bachelor's degree in a health-related field

·        Clinical background (RN preferred) or relevant quality credential

·        5+ years of experience in value-based care, quality improvement, or population health.

·        3+ years of experience in a health plan, IPA, MSO, or integrated delivery system.

·        Experience managing performance across multiple-payer contracts.

·        Prior leadership and people management experience.

Why Join NSIPA?

·        High-impact leadership role with direct influence on organizational strategy.

·        Opportunity to shape the future of value-based care across diverse populations.

·        Collaborative, mission-driven environment focused on improving patient outcomes.

·        Visibility, growth, and the ability to build and scale performance programs.

Physical Demands:

The physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; walk; sit for extended periods of time; use hands to finger, handle, or feel; make precisely coordinated movements of the fingers of one or both hands to grasp, manipulate, or utilize computer equipment; reach with hands and arms; and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, ability to adjust focus and ability to match or detect differences between colors, including shades of color and brightness.

EEO Statement:

NSIPA is an equal opportunity employer committed to diversity and inclusion. We encourage applications from all qualified individuals regardless of race, color, religion, gender, sexual orientation, age, national origin, disability, or veteran status.

Job Details:

Global Pharmaceutical Company

QA Shop Floor - 3rd Shift

Fort Washington, PA - Onsite

Long Term, Ongoing Contract

Pay rate $25-30/hr

QA Shop Floor - 3rd shift

Must be able to work four 10 hour days, Sun to Wed 9:30pmEST to 8:00AMEST or

Wed to Sat: 9:30pmEST to 8:00AMEST

Responsible for maintaining quality records, assisting with corrective action plans, and supporting quality system improvements. You will collect and organize data, prepare reports, and ensure inspection readiness while addressing routine quality inquiries.

Key Responsibilities

Collaborate with cross-functional teams to implement innovative quality assurance protocols on the shop floor, ensuring seamless production flow and minimal defects.

Utilize data-driven insights to proactively identify potential quality issues and develop creative solutions to enhance product reliability.

Engage in hands-on inspection of products, applying a keen eye for detail to uphold stringent quality standards.

Performs batch records review and cleaning records review to ensure product availability.

Support work orders review and confirm area cleanliness after maintenance interventions.

Performs area walkthroughs to ensure audit readiness at all times.

Contribute to continuous improvement initiatives by suggesting and piloting novel QA methodologies tailored to dynamic manufacturing environments.

Document and communicate quality findings through clear, concise reports that facilitate swift decision-making and process optimization.

Maintain accurate and timely quality records related to product inspections, nonconformance, and project outcomes.

Assist in documenting, monitoring, and following up on corrective and preventive action plans to ensure their effective implementation and closure.

Respond to routine inquiries regarding technology transfer and improvements in manufacturing processes.

Collect, organize, and analyze data to prepare detailed reports for assigned quality processes.

Document and implement improvements to quality systems and standard operating procedures, including maintaining SOPs for interactions with contract manufacturers.

Gather and maintain documentation required for audits and inspections to ensure inspection readiness.

Support special quality projects and contribute to continuous quality improvement initiatives.

Required Qualifications

Bachelor’s degree or equivalent qualification in Engineering, Quality Management, Science or a related field demonstrating foundational technical knowledge.

2 years of practical experience or internships in quality assurance, manufacturing, or related operational environments.

Strong attention to detail and ability to maintain accurate documentation.

Basic understanding of investigations and automation processes.

Ability to collect, organize, and analyze data effectively.

Good communication skills to respond to routine technical inquiries.

Ability to work independently.

Ability to work night shifts and weekends.

Desired Qualifications

Strong analytical mindset with the ability to interpret complex data and translate it into actionable quality improvements.

Excellent communication skills to effectively collaborate with diverse teams and articulate quality concerns innovatively.

Familiarity with quality systems, audits, and inspection readiness.

Proactive learner with a passion for adopting emerging QA technologies and methodologies to drive shop floor excellence.

Proactive approach to supporting special quality projects and continuous improvement.

On behalf of our growing manufacturing/injection molding client, located in Sterling Heights, MI, we are currently recruiting an experienced Quality Team Leader to join their team.

NOTE:

• Afternoon & Midnight Shift availability

RESPONSIBILITIES:

• Ensure compliance with ISO 9001:2015, IATF 16949, and the company’s Quality Management System (QMS), including adherence to the Quality Manual, policies, and procedures
• Perform quality inspections (first-off, last-off, and in-process) including visual inspections, measurements, fixture checks, and recording inspection data accurately
• Identify, document, and disposition nonconforming parts, report defects or machine malfunctions, and notify supervisors or quality personnel of discrepancies
• Maintain controlled documents, quality records, and inspection data, and support data analysis, reporting, and tracking of quality metrics (e.g., cost of poor quality, layered audits)
• Support continuous improvement initiatives by participating in problem-solving activities (e.g., 8D, team meetings), investigating quality issues, and recommending corrective actions
• Train employees and follow all safety and operational procedures, while assisting with packaging, handling, and transport of produced parts as required

REQUIRED SKILLS & QUALIFICATIONS:

• High School Diploma or Equivalent work experience at minimum
• 2 years prior work experience in plastics or automotive manufacturing industry
• Ability to use various measurement techniques
• Supervision experience an asset
• Training experience
• Effective communication skills, verbal, and written
• Computer skills & data analysis

COMPENSATION & BENEFITS:

• $22.00 - $23.00 / hour (depending on experience)
• Cost-sharing medical & dental benefits after 30 days
• 401K plan after 90 days

MEDA offers an excellent referral bonus. Great candidates know great candidates.

ROTHA Contracting Company, Inc. is seeking a Quality Control Manager/Construction Inspector to support roadway, bridge, and heavy civil construction projects for State and public agencies. The Quality Control Manager is responsible for developing, implementing, and maintaining project-specific Quality Control Programs to ensure construction activities are executed in accordance with contract documents, DOT specifications, permits, and regulatory requirements.

Key Responsibilities

• Develop, implement, and maintain a project-specific Quality Control (QC) Program
• Conduct and oversee field inspections from an onsite field office to verify work complies with plans, specifications, and contract documents
• Monitor materials testing and ensure proper Quality Assurance / Quality Control documentation
• Identify and document field conditions that may impact quality, schedule, or compliance
• Ensure work meets DOT, environmental, permit, and company quality standards
• Perform periodic reviews of QC processes to verify adherence to project and company standards
• Provide guidance and direction to project teams and field staff regarding quality control requirements and procedures
• Support continuous improvement of quality control practices within assigned projects through process refinement.
• Prepare and submit daily and monthly Quality Control reports
• Maintain accurate QC records including inspections, testing, certifications, and non-conformance reports
• Track corrective actions and preventive measures
• Organize and maintain QC documentation for audits and project closeout
• Coordinate with Project Managers, Superintendents, and engineers to resolve quality issues; coordinate with certified testing laboratories and additional QC personnel as required
• Support project teams with interpretation of quality-related contract requirements and inspection criteria

Required Qualifications

• Bachelor’s degree in Civil Engineering or Construction Management, or related field preferred. Relevant work experience in heavy civil/infrastructure construction will be considered
• Minimum 8 years of experience in a combination of: field inspection, heavy civil construction or construction management, and/or quality control or quality assurance roles
• Prior experience on DOT or public infrastructure projects
• Strong ability to read and interpret construction drawings, specifications, and contract documents

Physical Requirements

• Ability to work in an active outdoor construction environment in various weather conditions
• Ability to walk construction sites regularly and access all areas of active construction

Certifications / Licenses

NETTCP Quality Assurance Technologist certification preferred; willingness to obtain NETTCP certification if not currently held

Compensation

Based on experience and qualifications

Benefits Package

Health Insurance

401(k) eligibility with 6% company match

Company issued mobile device.

Paid time off and paid holidays

Annual bonus opportunities

Overtime opportunities

Job Summary:

The Quality Control Technician will operate to provide quality testing expertise for raw and finished product materials. The person in this role will interact with all local staff. They will be knowledgeable of the Quality requirements. They will ensure that laboratory procedures and equipment are kept in superior working order. Handling and disposing of Hazard waste and chemicals are part of normal activities.

Job Content

• Perform Lab Tests: Independently carry out routine quality control analyses following set procedures.
• Data Integrity & Documentation : Confidently handle all steps of testing, including preparation, execution, and accurate documentation.
• Check Results: Review test results for accuracy and consistency before submission.
• Report Issues: Identify and report any quality deviations (e.g., OOS) according to protocols.
• Initial OOS Testing: Conduct first-level tests for out-of-spec results as per procedures.
• Escalate Issues: Identify recurring problems and escalate them to the appropriate person or team.
• Maintain Equipment: Take care of assigned lab equipment, including calibration and basic maintenance, following GMP and safety standards.
• Meet Deadlines: Complete tests and submit results within required timeframes.
• Follow Safety Rules: Work in line with all safety, health, and environmental (SHE) guidelines.
• Problem Solving: Analyze special samples to help resolve lab or support in production issues.
• Manage Supplies: Order and manage lab materials and reagents to avoid shortages.
• Flexibility: Perform other tasks as needed to support lab operations.
• Physical requirements: Requires stand for extended periods while performing inspections or quality checks, repetitive hand and arm movements to handle samples and to operate testing equipment, ability to maintain focus and attention to detail during routine and repetitive tasks.

Knowledge and educational level

• Education: Bachelor's degree in Science, or a related field preferred.
• Experience: Minimum of 2 years of experience in quality control.
• Fluency in local language a requirement, other languages encouraged.

• Maintain the identification, segregation, documentation, and disposition of nonconforming product within the DC.
• Ensure no nonconforming product is shipped without formal approval.
• Track trends in damages, mislabels, and packaging issues.

• Shipping errors
• Missing or incorrect items
• Packaging failures
• Transportation damage
• Apply structured problem-solving (8D, 5 Why, Ishikawa).
• Define and follow up on corrective actions with Operations, Logistics, and Carriers.
• Communicate complaint status and risks to internal stakeholders.

• Maintain DC-specific procedures, work instructions, and records.
• Coordinate internal audit schedules and support external audits.
• Ensure document control and compliance with ISO requirements.

• Plan and execute internal audits for receiving, storage, picking, packing, and shipping.
• Document findings and ensure timely closure of corrective actions.
• Validate adherence to Standard Work and packaging standards.

• Implement Lean tools (5S, standardization, Poka-Yoke, Kaizen) in warehouse processes.
• Analyze data to reduce:
• Shipping errors
• Transportation damage
• Rework and repacking
• Cost of Poor Quality (COPQ)
• Support cross-functional improvement projects.

• Lead root-cause analysis for internal defects and customer complaints.
• Validate effectiveness of corrective actions through data and audits.
• Identify risks in packaging, labeling, handling, and storage processes.

• Train warehouse personnel on:
• Defect detection
• Packaging standards
• Escalation processes
• Handling of nonconforming product
• Promote quality ownership across all shifts.

• Bachelor’s degree in engineering
• Experience in manufacturing quality, process engineering, or related technical roles.
• Knowledge of ISO 9001 Quality Management Systems.
• Proficiency in problem-solving tools (8D, 5 Why, Ishikawa, A3 etc.).
• Ability to read and interpret technical drawings and specifications.
• Strong analytical, communication, and cross-functional collaboration skills.

• Experience in HVAC, automotive, or high-volume manufacturing environments.
• Knowledge of APQP, PPAP, PFMEA, Control Plans, MSA, and SPC.
• Experience with supplier defect notifications
• Lean or Six Sigma certification (Green Belt preferred).