GMP Compliance Investigator

Duke Careers • Durham, NC

82d

About The Position

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.

Requirements

• Bachelor's degree in a biological Science.
• Six years of experience in 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.

Nice To Haves

• Experience with successfully seeing a product from process development to clinical trials and, if applicable, through commercial FDA-licensure.
• Experience participating in FDA inspections, and other regulatory, accreditation and sponsor audits.

Responsibilities

• Enable compliance of the Carolinas Cord Blood Bank (CCBB) with FDA regulations and FACT accreditation standards.
• 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).
• 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.
• Assist in the process for FACT accreditation, performing gap analysis against the standards and identifying areas to fill.
• 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.
• Prepare sites and manufacturing facility for inspections by these agencies and internal audits.

Benefits

• Health insurance plans
• Generous paid time off
• Retirement programs with employer contributions
• Tuition assistance for employees and their children

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees