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

About the role

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.

Responsibilities

• Enable compliance of the MC3 Robertson GMP manufacturing laboratory with FDA regulations and FACT accreditation standards.
• 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.
• Maintain deviation, memo, and CAPA timelines to meet timely Batch Release.
• Provide Compliance Assistance on Batch Release Documentation.
• 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.
• Monitor Quality Agreements with sponsors to ensure timely notification of events as required per each specific agreement.
• Participate in continuous process improvement projects as directed by the Associate Director, GMP Compliance to ensure continuous optimization of SOPs.

Requirements

• Education/Training: Bachelor's degree in a biological science.
• Experience: 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.

Qualifications

• 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.

Skills

• 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.

Benefits

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.

Pay

Your total compensation goes beyond 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/

Schedule

Not specified.