GMP Compliance Investigator

Job Title: QA Regulatory and Compliance Associate This Position is Grant Funded 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. Preferred Qualifications 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. Occupational Summary 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 Performed Enable 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. Skills 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 Equal Employment Opportunity Statement Duke University 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 on collaboration, 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 provision for requests for reasonable accommodation will be provided by each hiring department. #J-18808-Ljbffr Duke Clinical Research Institute