GMP Compliance Investigator - Equipment and Facilities - Marcus Center for Cellular Cures

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Be You.

Duke University’s Marcus Center for Cellular Cures has an immediate opening for a QA Regulatory and Compliance Associate in their GMP lab located at 2400 Pratt Street Durham, NC. This position is currently on - site.

The ideal candidate will have relevant knowledge and industrial experience in the field of bioprocess development for manufacture of cellular and tissue-based therapies and will have experience transferring processes to cGMP facilities for clinical or commercial manufacture.

They are expected to possess a high level of skill and experience with key bioprocess techniques and cGMP production including cell culture and bioreactor operation and scale-up, or experience from the Quality Assurance perspective for these processes.

Minimum Qualifications:

Education/Training

Work generally requires a bachelor's degree in a biological Science.

Experience

Work requires six years of experience quality assurance or quality control related to clinical trials.

A Master's degree in a related field may be substituted for 2 years of required experience or an equivalent combination of relevant education and/or experience.

Occupational Summary

• Enable compliance of the MC3 Robertson GMP manufacturing laboratory with FDA regulations and FACT accreditation
• standards. As directed by the Associate Director, GMP Compliance, develop and edit Standard Operating Procedures (SOPs)
• related to the manufacturing of GMP products in the Robertson GMP Laboratory to ensure compliance with FDA and other
• applicable requirements. Edit batch records as needed. Initiate, author and complete deviations, CAPAs, memos and
• investigations related to manufacturing. Collaborate with QSU and manufacturing teams to investigate errors and complete
• deviations and CAPAs. Monitor Quality Agreements with sponsors to ensure timely notification of events as required per each specific agreement.

Work Performed

• As directed by the Associate Director, GMP Compliance, develop and edit Standard Operating Procedures (SOPs the Robertson
• GMP Laboratory to ensure compliance with FDA and other applicable requirements. Develop, author and complete change
• control request for SOP updates. Edit batch records as needed. Work closely with the Process Development team to establish
• SOPs for new manufacturing processes or optimization of existing ones.
• Initiate, author and complete deviations and investigations related to manufacturing SOP excursions. Collaborate with
• manufacturing and Quality to investigate errors and complete deviations and Corrective and Preventive Actions (CAPAs). Ensure
• timely signoff of deviations and CAPAs to enable product release.
• Attend meetings/ interviews with vendors and equipment representatives to ensure all relevant details are gathered to support
• deviation investigations.
• Author validation (installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ)) protocols,
• equipment assessments and validation reports.
• Serve as primary author for deviation reports related to equipment and facilities events.
• Manage and drive closure of deviations, CAPA and change controls by working with key stakeholders.
• Failure Mode Analysis- assessing deviations to determine the failure modes that contribute to deviation root cause
• Develop and edit Standard Operating Procedures (SOPs) related to the manufacturing of GMP products in the Robertson GMP Laboratory to ensure compliance with FDA and other applicable requirements.
• Ensure all deviation, memo, and CAPA timelines are maintained to meet timely Batch Release
• Provide Compliance Assistance on Batch Release Da
• Enable compliance of the MC3 Robertson GMP manufacturing laboratory with FDA regulations and FACT accreditation standards.
• Educate staff regarding both new and updated policies and procedures, FACT standards, manuals, SOPs, training, and quality plans. Assist in inspections from FDA, FACT, and other agencies. Review observations and provide input to respond to the observations.
• Monitor Quality Agreements with sponsors to ensure timely notification of events as required per each specific agreement.
• Work in continuous process improvement projects as directed by the Associate Director, GMP Compliance to ensure continuous optimization of SOPs

Preferred Skills

The ideal candidate will have relevant knowledge related to working in a quality or compliance function within an FDA related cellular therapy manufacturing facility. A background in auditing and writing reports would be beneficial. The preferred candidate

would also have experience participating in FDA inspections, and other regulatory, accreditation and sponsor audits.

The ideal candidate is expected to possess experience within a manufacturing or quality assurance function with particular emphasis on the writing, review, and approval of deviations, CAPA’s, and change controls request. This position will primary be

writing reports thus a keen eye for detail and a background in technical writing would be ideal.

Other preferred skills include:

• Experience working with electronic QMS software
• Project management experience
• Excellent communication skills, both written and oral
• Ability to pay attention to detail
• Excellent organizational skills
• Outstanding interpersonal skills
• Excellent analytical skills, good judgment, strong operational focus
• Self-directed team player
• Concise Data Gathering

The preferred candidate will have experience with successfully seeing a product from process development to clinical trials and, if applicable, through commercial FDA-licensure. The preferred candidate would also have experience participating in FDA inspections, and other regulatory, accreditation and sponsor audits.

Choose Duke.

Join our award-winning team as identified by Forbes magazine as America’s Best Large Employer 2024 and be part of an inclusive culture that values excellence, innovation, and discovery. As an organization, we have exciting opportunities to be forward-thinking leaders in our field. We want talented individuals to join us, examine our current operations, and create innovative solutions that will revolutionize and enhance the way we approach our work.

Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines.

Beyond the engaging work, you'll also benefit from Duke'scompetitive benefits package including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.

Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $67,919.00 to USD $102,898.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goesbeyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/

Equal Opportunity Employer: Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender,gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status.

Duke aspires to create a community built oncollaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions:

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: [email protected]; phone: 919-668-1267).