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.
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.
In addition, 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.
More information about this lab is located at the link below: https://marcuscenter.duke.edu/resources/robertson-gmp-lab
Minimum Requirements:
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
Position Description:Enable compliance of the MC3's Carolinas Cord Blood Bank (CCBB) with FDA regulations and FACT accreditation standards. As directed by the GMP Compliance Associate Director, initiate and complete deviations and investigations, CAPAs, memos to file, complaints, and adverse events related to the collection, manufacturing and review of GMP cellular product. Collaborate with the Quality Systems Unit (QSU), collection, manufacturing and review teams to investigate errors and identify any Corrective and Preventative Actions (CAPAs). As applicable and as identified as part of a CAPA, develop and/or edit Standard Operating Procedures (SOPs) related to the manufacturing of GMP products in the CCBB to ensure compliance with FDA and other applicable requirements. Review/correct batch records as needed. Conduct internal program audits.
Work PerformedEnable compliance of the Carolinas Cord Blood Bank (CCBB) with FDA regulations and FACT accreditation standards. Assist in the process for FACT accreditation, performing gap analysis against the standards and identifying areas to fill, develop and update SOPs as needed to address those gaps. 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.
As directed by the GMP Compliance Associate Director, and as related to CAPAs, develop and edit Standard Operating Procedures (SOPs) for the CCBB to ensure compliance with FDA and other applicable requirements. Edit batch records as needed.
Initiate and complete deviations and investigations and CAPAs related to CCBB SOP excursions. Collaborate with QSU to investigate errors and complete deviations and CAPAs. Ensure timely signoff of deviations and CAPAs. Initiate, investigate and complete complaints and adverse events related to the collection and manufacturing and distribution of GMP cellular product. Review/correct batch records as needed.
Prepare sites and manufacturing facility for inspections by these agencies and internal audits by performing periodic internal audits with a focus on review of equipment maintenance, safety procedures, training records, and SOP compliance.
Serve as the liaison between the CCBB and QSU to schedule internal audits by QSU and collaborate with the respective CCBB area leaders to prepare a response to audit and inspection findings.
Other preferred skills include:
- 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
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
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/
