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

Duke Careers•Durham, NC

38d•$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 related to working in a quality or compliance function within an FDA related cellular therapy manufacturing facility.
Background in auditing and writing reports.
Experience participating in FDA inspections, and other regulatory, accreditation and sponsor audits.
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.
Keen eye for detail and a background in technical writing.
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.
Experience with successfully seeing a product from process development to clinical trials and, if applicable, through commercial FDA-licensure.

Responsibilities

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.
Develop, author and complete change control request for SOP updates.
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.
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.
Ensure all deviation, memo, and CAPA timelines are maintained to meet timely Batch Release.
Provide Compliance Assistance on Batch Release Da.
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.
Work in continuous process improvement projects as directed by the Associate Director, GMP Compliance to ensure continuous optimization of SOPs.