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

Work Arrangement:

Requisition Number: 241040

Regular or Temporary: Regular

Location:

Durham, NC, US, 27710

Personnel Area: MEDICAL CENTER

Date: Apr 20, 2024

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Duke University’s Marcus Center for Cellular Cures (MC3) has an immediate opening for a GMP Compliance Investigator – Equipment and Facilities in our GMP Manufacturing Laboratory.

Our Vision: To live in a world where every person has access to high quality and effective cell based therapies

Our Mission: Together we design, develop and deliver the highest quality cellular therapies to improve health

More information is available at the following link: https://marcuscenter.duke.edu/

Occupational Summary

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.

Work Performed

As directed by the Associate Director, GMP Compliance, develop and edit Standard Operating Procedures (SOPs the Robertson GMP Laboratory to ensure compliance with FDA and other applicable requirements. Develop, author and complete change control request for SOP updates. Edit batch records as needed. 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. Collaborate with manufacturing and Quality to investigate errors and complete deviations and Corrective and Preventive Actions (CAPAs). 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

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.

Ensure all deviation, memo, and CAPA timelines are maintained to meet timely Batch Release

Provide Compliance Assistance on Batch Release Day

Enable compliance of the MC3 Robertson GMP manufacturing laboratory with FDA regulations and FACT accreditation standards.

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.

Work in continuous process improvement projects as directed by the Associate Director, GMP Compliance to ensure continuous optimization of SOPs.

Preferred Skills

The ideal candidate will have relevant knowledge related to working in a quality or compliance function within an FDA related cellular therapy manufacturing facility. A background in auditing and writing reports would be beneficial. The preferred candidate would also have experience participating in FDA inspections, and other regulatory, accreditation and sponsor audits.

The ideal candidate is expected to possess 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. This position will primary be writing reports thus a keen eye for detail and a background in technical writing would be ideal.

Other preferred skills include:

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

Minimum Qualifications

Education

Work generally requires a bachelor's degree in a biological Science.

Experience

Work requires six years of experience quality assurance or quality OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE control related to clinical trials. A Master's degree in a related field may be substituted for 2 years of required experience.

Duke is an Affirmative Action/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, sexual orientation, or veteran 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 essentialjob 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.