Engineering Jobs in Dayton Middlesex County, NJ
39 positions found — Page 2
About Made Scientific
Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.
Position Summary
The Manufacturing Supervisor provides leadership to the Sterile Production Team, ensuring high-quality operations, regulatory compliance, and adherence to cGMP standards. This role oversees daily production activities, supervises cleanroom environments, and drives continuous improvement through collaboration, problem-solving, and monitoring of key performance metrics.
The position also involves developing and mentoring team members, promoting a positive and safe work culture, and ensuring consistent alignment with Made Scientific’s mission to deliver life-changing therapies.
Key Responsibilities
• Provide strategic direction to the Sterile Production Team, ensuring alignment with the organization’s core values and commitment to high-quality outcomes.
• Oversee sterile production operations, ensuring compliance with cGMP, regulatory requirements, and production schedules while maintaining accurate documentation, SOPs, and equipment standards.
• Supervise daily operations, spending approximately 50% of time in cleanroom environments, reviewing batch records, and addressing production issues to ensure product quality and safety.
• Support continuous improvement through root cause analysis, feedback, and monitoring of KPIs to improve metrics such as scrap, non-conformance, and plant efficiency.
• Lead hiring, training, and performance management initiatives to build a skilled, engaged, and safety-focused team.
• Foster a collaborative and compliant work culture with strong adherence to environmental, health, and safety standards.
• Partner cross-functionally with Quality, Engineering, and Process Development teams to support operational alignment and improvement projects.
• Perform other duties as assigned.
Required Qualifications
• Bachelor’s degree in Science, Engineering, or a related field, or equivalent experience.
• Minimum 4 years of operations experience within a cGMP environment in the biotech or biopharma industry.
• Minimum 1 year of leadership, supervisory, or management experience (preferred).
• Prior experience in manufacturing, quality, or engineering is required.
• Excellent communication, leadership, and organizational skills.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).
• Strict adherence to SOPs, GMP regulations, FDA guidance, and documentation best practices.
Preferred Qualifications
• Experience with cell therapy automation technologies, closed-system culture vessels, cell washers, and cell separation technologies for autologous/allogeneic product manipulation.
• Hands-on experience in handling, propagation, isolation, activation, and cryopreservation of human primary cells, including T cells.
Physical Requirements
• Ability to safely and successfully perform essential job functions consistent with ADA, FMLA, and other applicable standards, including meeting productivity expectations.
• Regular, punctual attendance is required.
• Must be willing to be gown-qualified and work in CNC/ISO8/ISO7 cleanroom environments.
• Must be able to lift up to 25 lbs.
• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.
• Must be able to sit or stand for extended periods.
• Must be willing to work with cell-based products, chemicals, and hazardous materials.
Work Schedule
• Must be available to work weekends, holidays, and extended hours as required to meet production needs. Flexibility to accommodate changing production schedules is expected.
About Made Scientific
Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.
Position Summary
The Manufacturing Associate will support Cell Therapy Operations at our GMP-compliant facility, playing a critical role in the production of cutting-edge cell therapies. This position is ideal for a detail-oriented professional with strong aseptic technique and a proven ability to quickly master complex processes in a cleanroom environment. The successful candidate will demonstrate a deep commitment to current Good Manufacturing Practices (cGMP) and thrive in a collaborative, quality-driven setting. This role requires precision, adaptability, and a strong quality mindset to ensure the consistent delivery of high-standard therapeutic products.
Key Responsibilities
• Perform aseptic manufacturing operations within a classified cleanroom environment, ensuring compliance with all cGMP and safety standards.
• Execute complex procedures for cell therapy manufacturing and sterile product operations—including cell culture, formulation, and cryopreservation—while maintaining strict adherence to written procedures, batch records, and cGMP regulations.
• Operate and maintain specialized manufacturing equipment, ensuring proper calibration and functionality.
• Monitor and document all production processes with precision, ensuring traceability and compliance with regulatory standards.
• Identify and escalate deviations or non-conformances; participate in root cause analyses and implement corrective actions.
• Collaborate cross-functionally with Quality, Process Development, and Engineering teams to support continuous improvement initiatives.
• Perform routine cleanroom maintenance, including environmental monitoring, cleaning, and sterilization activities.
• Maintain an organized, compliant workspace by following 5S principles and minimizing contamination risks.
• Participate in training sessions to stay current with manufacturing techniques, quality standards, and safety protocols.
• Support process development activities during technology transfer.
• Aseptically gown and work in ISO 8, 7, and 5 cleanroom environments and stand for extended periods.
• Assist in creating and reviewing Standard Operating Procedures (SOPs) and Master Batch Records (MBRs).
• Review MBRs daily to ensure documentation is accurate and complete.
• Participate in audits, inspections, qualifications, and validation activities.
• Handle chemicals such as corrosives, solvents, and biohazardous materials safely.
• Perform other duties as assigned.
Required Qualifications
• Bachelor’s degree in Biology, Biotechnology, or a related field preferred; equivalent experience will be considered.
• 1–3 years of experience in GMP manufacturing, preferably in cell therapy, biologics, or pharmaceutical CDMO operations.
• Strong knowledge of aseptic techniques and cleanroom protocols.
• Proficiency in basic mathematical concepts, including scientific notation.
• Proven ability to learn and master complex processes quickly.
• Exceptional attention to detail with a strong commitment to quality standards.
• Excellent collaboration, communication, and interpersonal skills.
• Ability to work effectively in a fast-paced, dynamic environment with shifting priorities.
Preferred Qualifications
• Experience in aseptic cell culture processing in ISO 5 biosafety cabinets, using universal precautions for handling human-derived materials.
• Familiarity with cell therapy automation technologies, closed system culture vessels, cell washers, and cell separation technologies for autologous or allogeneic product manipulation.
• Experience handling, propagating, isolating, activating, and cryopreserving human primary cells, including T cells.
• Proficiency in basic computer applications (e.g., Microsoft Office, electronic batch record systems).
Physical Requirements
• Ability to stand for extended periods and perform repetitive tasks in a cleanroom environment.
• Must be able to lift up to 25 lbs. and work in full cleanroom gowning and PPE for extended durations.
• Ability to perform essential job functions safely and successfully in compliance with ADA, FMLA, and other applicable standards, including meeting productivity expectations.
• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.
• Must be comfortable working with cell-based products, chemicals, and hazardous materials.
Work Schedule
• Must be available for shift work, including off-shift hours, weekends, and holidays, as needed to meet production demands. Flexibility to accommodate changing production schedules is required.
Job Title: Bid Manager / Project Controller
Location: Piscataway, New Jersey
Salary: Up to $110,000 (based on experience)
Full-Time | Competitive Benefits
Join Our Team in Piscataway, NJ
We are seeking a detail-oriented and strategic Bid Manager / Project Controller to join our growing team in Piscataway - the right candidate will be incredibly detail oriented. This role is ideal for a professional who excels at managing bids, overseeing project financials, and ensuring operational excellence from proposal through execution.
With a competitive salary of up to $110,000, this is an excellent opportunity to play a critical role in driving project success and business growth.
Key Responsibilities
- Excellent and proven attention to detail. The rest can be taught!
- Lead and coordinate the end-to-end bid and proposal process
- Prepare cost estimates, pricing models, and financial analyses
- Develop and maintain project budgets, forecasts, and cost controls
- Monitor project performance against financial and operational targets
- Identify risks and implement mitigation strategies
- Collaborate with engineering, operations, finance, and leadership teams
- Support contract negotiations and ensure compliance with client requirements
- Produce detailed reporting for senior management and stakeholders
Qualifications
- Bachelor’s degree in Business, Finance, Engineering, or related field
- 3+ years of experience in bid management, project controls, or financial project oversight
- Strong financial acumen and analytical skills
- Experience with budgeting, forecasting, and cost tracking
- Excellent organizational and communication skills
- Proficiency in Excel and project management software
- PMP or similar certification (preferred but not required)
Princeton Theological Seminary, established in 1812, is dedicated to forming Christian leaders to serve Christ's church, academia, and the world. Located in Princeton, NJ, the institution is renowned for its commitment to theological education and fostering a community of faith and learning. The Seminary combines academic excellence with a rich history, providing an environment for students to grow spiritually and intellectually. With a global perspective, it prepares faith-driven leaders for impactful service.
This is a full-time, on-site Electrician role based in Princeton, NJ. The Electrician will perform installation, maintenance, and repair of electrical systems and equipment across campus facilities. Responsibilities include diagnosing and troubleshooting electrical issues, performing routine preventative maintenance, ensuring code compliance, and collaborating with the facilities team to uphold safety standards. The candidate will be required to handle various electrical tasks, ensuring operational efficiency for a safe environment.
- Proficiency in Electrical Work and Electricity, with the ability to install and maintain electrical systems
- Strong background in Maintenance & Repair tasks, ensuring equipment functionality and safety
- Skilled in Troubleshooting, identifying, and resolving electrical issues efficiently
- Understanding of Electrical Engineering principles and code compliance
- Excellent problem-solving and organizational skills
- Relevant certifications and licenses to perform professional electrical work
- Ability to work independently and collaboratively as part of a team
- Prior experience in facility management or academic settings is a plus
You'll work closely with clients, project managers, and a talented engineering team to ensure every project meets specifications, stays on schedule, and stays within budget.
No relocation assistance available for this position.
Not available for hybrid working hours- must live in or around the Somerset WI area.
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Location: 160 Princeton Hightstown Road, East Windsor NJ 08520
Rate of Pay: Rate of pay: $84,469 - $103,320 per year
Job Overview
The Warehouse Management Systems (WMS) Analyst serves as the on-site liaison between the operations management team and the Information Technology team, and plays a role of a super user in the utilization of the system. They would be responsible for day-to-day system maintenance and troubleshooting. First point of contact for assistance, questions, issues, training others, etc. at the operations level. Work with Operations teams, IT, and Engineering groups to ensure optimal configurations for WMS conversions, enhancements, and new business requirements.
Job Responsibilities and Essential Duties
- Conduct organizational studies and evaluations, design systems and procedures, conduct work simplification and measurement studies, and prepare operations and procedures manuals to assist management in operating more efficiently and effectively. Includes program analysts and management consultants.
- Serves as the on-site liaison between the Operations Management and Information Technology teams, acting as a super user of the Warehouse Management System (WMS).
- Responsible for day-to-day system maintenance and troubleshooting, and functions as the first point of contact for operational-level assistance, including user questions, issues, and training. Collaborates with Operations, IT, and Engineering teams to ensure optimal system configurations for WMS conversions, enhancements, and new business requirements.
Minimum Requirements
- Bachelor's degree in a STEM field plus 3 years of experience in warehouse management systems, or related.
- A minimum of 3 years of related systems experience.
Required Knowledge, Skills, and Abilities
- Requires skills and experience to involve: Expert-level knowledge of Blue Yonder WMS from an operational perspective, including data mining, issue investigation, system adjustments, and development of best practices.
- Hands-on experience managing warehouse zones, including movement paths, storage zones, pick zones, and count zones, to ensure efficient workflow and inventory accuracy.
- Proven ability to troubleshoot RF (radio frequency) issues, ensuring minimal disruption to daily operations. Expertise in barcode configuration and management, supporting accurate and efficient inbound, picking, and pack-out processes across multiple product lines.
- Strong background in waving processes and shortage resolution, critical to ensuring on-time order fulfillment.
- Experience testing within Blue Yonder WMS environments, following documentation best practices to ensure system reliability and consistency.
- Skilled in troubleshooting support requests related to WMS and integrated systems or interfaces.
- Experience developing and maintaining SOPs and site-specific process documentation to ensure consistent and efficient operations.
- Familiarity with shipping quality guidelines, and extensive experience in inventory management and quality control to ensure operational excellence.
Supervision/Management of Others:
- The position does not supervise other employees
Internal and External Contacts/Relationships
- Internal: Warehouse and Logistics team, Getinge employees
- External: Working relationships with external vendors, operations, and IT team members
Environmental/Safety/Physical Work Conditions
- Ensures environmental consciousness and safe practices are exhibited in decisions
- Use of computer and telephone equipment and other related office accessories/devices to complete assignments
- May work extended hours during peak business cycles
Permissions
Each organization shall establish the appropriate authority, and interrelation of all employees who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.
Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
At Getinge, we offer a comprehensive benefits package, which includes:
* Health, Dental, and Vision insurance benefits
* 401k plan with company match
* Paid Time Off
* Wellness initiative & Health Assistance Resources
* Life Insurance
* Short and Long Term Disability Benefits
* Health and Dependent Care Flexible Spending Accounts
* Commuter Benefits
* Parental and Caregiver Leave
* Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
Who we are:
Atkore is forging a future where our employees, customers, suppliers, shareholders, and communities are building better together - a future focused on serving the customer and powering and protecting the world.
With a global network of manufacturing and distribution facilities worldwide, Atkore is a leading provider of electrical, safety and infrastructure solutions.
Who we are looking for:
We are currently looking for a BIM Technician to be based out of Tampa, FL reporting to the Drafting Manager. This person will be responsible for working with the project team to develop accurate and complete modeling drawing sets. The BIM Technician will ensure the integrity of project drawings while maintaining privileged information per the customer and company requirements.
What you'll do:
- Accurately identify product specifications and understand of detail assemblies and their application for installation.
- Create or revise/update construction drawings, maintaining a tracking log of drawings.
- Review drawings for accuracy and scope of work, ensuring quality of final drawings.
- Collaborate with team and customers to ensure that projects are successfully completed, and best practices/technical issues are addressed.
- Run the multi trade coordination for clashes to assist project team with the design process.
- Conduct clash detection and visual walkthroughs using Navisworks Manage.
- Research ways to continuously improve our process including providing insight into new time saving methodologies and best practices.
- Manage, maintain, and update BIM Project documents.
What you'll bring:
- Bachelor's (preferred) or Associates Degree in Architecture, Engineering, and Construction (AEC) related field with 1 to 3 years of industry experience.
- 1+ years' experience in 3D Revit or 3D AutoCAD.
- Technical certificates in Drafting and ED BIM Modeling training (preferred).
- Experience with Autodesk Revit, CAD, and BIM procedures (Preferred).
- Familiarity with Overhead coordination process including 3D Modeling utilizing Revit in project environment, Project As-builts and turnover for Facility management.
- Experience with Microsoft Office Suite, CAD and BIM systems including Autodesk AutoCAD, Revit Suite, BIM 360, Veo, Bluebeam, Word, Excel, and PowerPoint.
Within 3 months, you'll:
- Complete the onboarding material and training on companies' products and drafting processes.
- Collecting information from multiple plans and incorporating them into a model which can be used to build structural support.
- Produce 2D shop drawings and 3D models projects with assistance of PM and BIM Designer.
- Complete Atkore Immersion process.
Within 6 months, you'll:
- Communicate effectively with PM's and other team members in order to gather the information needed for each project.
- Develop strong knowledge of the companies' products and produce accurate designs based on each project needs.
- Assist with BIM Designer to coordination meeting and be part of BIM project development at different phases: modeling, cleaning clashes and producing shop drawings.
Within 12 months, you'll:
- Produce structural models and drawings using Revit and manage coordination projects.
- Manipulate and develop CAD library components for AutoCAD and Revit or other related software.
- Independently handle BIM project from start to finish by assisting to BIM Coordination, performing clash detection, and resolving coordination issues.
Atkore is a recipient of a Great Place to Work certification and a Top Workplaces USA award! We're committed to creating an engaged and aligned workforce that drives collaborative culture. Our team strives for breakthrough results, stays focused on being standout leaders, and fully supports decisions of the Company. We consistently live the Atkore mission, strategic priorities, and behaviors, all in a way that's consistent with our core values. Together, we build strong leaders that continually endeavor to move us forward.
With a global network of manufacturing and distribution facilities worldwide, Atkore is a leading provider of electrical, safety and infrastructure solutions.
Join our team and align yourself with an industry leader!
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
About the Role
The candidate will support technical documentation required for BLA submission, and ensure the QC organization is inspection ready. This position will also coordinate QC schedules, resource allocation, and testing timelines critical for successful BLA submission.
Responsibilities
- Support preparation and review of technical reports and QC documentation required for the BLA, ensuring timely completion and regulatory accuracy.
- Create, maintain, and monitor QC testing trackers, documenting tests, timelines, assigned analysts, sample workflows, and status updates.
- Facilitate and maintain a resource loading tracker, aligning personnel capacity with sample testing volume to ensure on-time data generation for the BLA.
- Escalate resource gaps, workflow delays, or testing challenges that could impact critical milestones.
- Support method transfer and method validation troubleshooting to ensure analytical readiness for BLA submission.
- Lead the establishment and maintenance of a stability program, ensuring data availability for regulatory filing.
- Participate in internal and external GMP audits, ensuring QC operations meet all regulatory expectations.
Required Qualifications
- Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, Biology, required
- 5+ years of experience in an FDA-regulated pharmaceutical with demonstrated experience supporting major regulatory submissions (e.g., BLA, NDA, MAA).
- 5+ years of experience in analytical chemistry methods including HPLC, UPLC, GC, TOC, and related instrumentation.
- Strong working knowledge of USP/EP, cGMP, EU GMP, and analytical compliance requirements.
- Proven experience tracking testing deliverables, coordinating QC schedules
Preferred Skills
- Technical writing expertise, including investigations, method documents, validation protocols/reports, and change control assessments.
- Ability to prioritize multiple deliverables and manage time effectively in a high-pressure, deadline-driven environment, especially in support of regulatory filing timelines.
We are a diverse, passionate team spread across the US, Canada, Mexico, and Puerto Rico, committed to growth, learning, and creating opportunities for each other.
At Turtle, every day is a chance to make a real difference, solve complex challenges, and push the boundaries of what’s possible.
We believe in fostering an environment that inspires collaboration and sparks creativity, where employees are empowered to contribute to our mission and shape the future of the industry.
If you're looking for a fast-paced, dynamic career where your ideas are valued and your growth is prioritized, Turtle is the place for you.
Join us and be a part of a company that’s making waves and empowering its people to do extraordinary things every single day! About the Role The Will Call Supervisor oversees daily will call and expedited order operations, ensuring orders are processed accurately, efficiently, and on schedule.
Responsibilities include completing all will call orders, capturing proof of delivery (POD) documentation, and coordinating expedited requests such as Turtle Express and courier pickups.
Additionally, this position manages the returns team and assists the AM Warehouse Supervisor and Manager in morning warehouse operations, maintaining a safe and organized work environment, enforcing safety policies, and supporting warehouse productivity.
Supervisors are cross trained in multiple operational areas and may provide coverage as needed to ensure efficient daily operations.
What You'll Do: Ensure all employees have required PPE and perform tasks safely.
Oversee daily will call operations (order picking, staging, and completion).
Properly capture and record will call proof of delivery (POD) documentation.
Coordinate expedited order requests (Turtle Express, courier pickups, priority orders).
Accurately receive all PO pickups into the system in a timely manner.
Sort relay orders to appropriate delivery routes and ensure paperwork is given to dispatch.
Supervise returns team to process returns accurately and promptly.
Support AM warehouse functions: replenishments, receipts, transfers, and putaways.
Inspect forklifts and powered industrial equipment before each shift.
Conduct toolbox and safety meetings with will call and returns teams as needed.
Complete daily operational checklists and document all will call and return activities.
Learn and enforce company agreements and working rules.
Complete near miss and/or accident reports as required.
Conduct or oversee new hire training in will call and returns areas.
Work with Quality and Safety Manager on training targets, including ADP requirements.
Coach employees to prevent repeated errors and improve performance.
Assist with warehouse labor as needed (picking, packing, other tasks).
Be cross-trained and provide coverage in multiple operational areas to ensure smooth daily distribution center operations.
What You'll Bring High school diploma or equivalent required.
Minimum of 3–5 years of warehouse or distribution center experience.
Previous experience in a lead, coordinator, or supervisory role preferred.
Strong understanding of warehouse operations including will call, receiving, returns, and order fulfillment processes.
Experience working with warehouse management systems (WMS), RF scanners, and inventory systems.
Ability to prioritize multiple tasks and manage expedited and time-sensitive orders.
Strong communication and leadership skills with the ability to coach and guide team members.
Working knowledge of warehouse safety standards and OSHA guidelines.
Ability to operate or become certified to operate forklifts and other powered industrial equipment.
Ability to lift 50 lbs.
and work in a fast-paced warehouse environment.
Proficiency with basic computer systems and Microsoft Office applications.
What We Offer We offer a competitive benefits package that includes: 401(k) plan Health insurance Dental insurance Vision insurance Life insurance Paid holidays Vacation Employee negotiated discounts Who We Are Founded in 1923, Turtle is a fourth-generation, family-owned, and three-generation women-owned business, and one of the nation’s largest independent electrical and industrial distributors.
Headquartered in Clark, NJ, our Electrical Distribution division operates 14 branches spanning from coast to coast.
It is a significant force in the engineering and procurement of power distribution, automation, lighting, and energy projects, offering integrated services for the industrial and construction markets.
Turtle Integrated provides on-site MRO procurement, cost-saving, and spend analytics across the US and in Canada, Puerto Rico, and Mexico.
What To Do Next You can begin by filling out our application online.
If you want to learn more about Turtle, please visit our website or our LinkedIn: @Turtle.
Turtle is proud to be is an equal opportunity employer that is committed to diversity and inclusion in the workplace.
We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, gender identity or expression, national origin, disability, genetic information, pregnancy, marital status, military or veteran status, or any other protected characteristic as outlined by federal, state, or local laws.
Global Product Quality Specialist
12-month Contract
Remote- EST Hours
Responsibilities:
- Quality Systems Support:
- Work collaboratively with internal and external partners to ensure deviations, investigations, OOS/OOTs, CAPAs and change controls adhere to quality system requirements and current GMP expectations.
- Support of regulatory submissions, annual reports and preparation of annual product quality reviews
- Inspection readiness for Internal and external audits
- Compile metrics for continuous improvement initiatives
- Assist in the writing of Quality Agreements
- Documentation Review:
- Review of API, DP and Packaging batch records
- Review of test methods, component specifications, validation protocols/reports, BOM
- Review of stability protocols and reports, and data in LIMS
- Operational QA Support:
- Work with external CDMOs and laboratories in the review of quality events, change controls, data review, and batch record documentation
- Creates and/or ensures on-time closure of Quality records in TrackWise Digital (batch records, deviations, change controls, investigations, CAPAs and effectiveness checks)
- Uploads and routes documents for approval in the company Electric Documentation Management System (Veeva) and DocuSign
- Project QA Support:
- Represent quality on cross-functional teams and provide support to ensure compliance with GMPs, FDA expectations, product specific requirements, and company standards are consistently met
- Ensure the review and release of clinical and commercial lots meet expected timelines to maintain an uninterrupted product supply
Qualifications:
- BS Degree in scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) or equivalent experience in a GMP-regulated environment
- 4 to 7 years of experience working within Pharmaceutical Quality, Engineering, Production or QC/Analytical Development function
- Ability to author and/or provide clear, concise, and technically accurate feedback on GMP documents (SOPs, deviations, CAPAs, investigations, protocols, reports)
- Attention to detail required to perform thorough document review, accurate data verification, and consistent application of right first time principles
- Working knowledge of ICH guidelines (e.g., Q7/Q8/Q9/Q10, Q12) and 21 CFR Parts 210/211 and/or EU GMPs, with the ability to apply these requirements to real-world manufacturing, testing, documentation, and release processes
- Experience with at least two QMS elements (e.g. Deviation, CAPA, Change Control)
- Strong written and verbal communication skills; ability to collaborate with cross-functional teams
- Proficiency with MS 365 (Word, Excel, PowerPoint, SharePoint/Teams).
- Experience with electronic QMS/eDMS (TrackWise, Veeva, LIMS) systems is a plus.