GMP QA Regulatory and Compliance Associate

Duke Careers•Durham, NC

4d•$67,919 - $102,898•Onsite

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 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

Relevant knowledge and industrial experience in the field of bioprocess development for manufacture of cellular and tissue-based therapies.
Experience transferring processes to cGMP facilities for clinical or commercial manufacture.
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.
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.
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

Responsibilities

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.
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.
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.