GMP, QUALITY ASSURANCE ASSOCIATE II
About the role
The Office of Regulatory Affairs & Quality (ORAQ) at Duke University is seeking a GMP, Quality Assurance Associate II to support the Marcus Center for Cellular Cures (MC3) GMP Facility. This role involves ensuring that all products, materials, and processes meet the highest standards of quality and compliance, with a focus on supporting the MC3 GMP Facility.
Responsibilities
- Support and evolve quality systems, including supporting investigations and building tools to analyze and assess quality metrics.
- Support robust supplier qualifications systems and inspection readiness planning and training.
- Guide teams on GMP expectations and support continuous improvement efforts.
- Shape continuous improvement efforts and support inspections.
- Represent QA in project meetings and provide quality guidance.
- Write, revise, and review Standard Operating Procedures (SOPs) to support compliant operations.
- Lead or support continuous improvement initiatives across GMP programs.
- Track and trend quality metrics to identify areas of concern.
- Assist with inspections and manage quality-related matters during audits.
- Review and guide deviations and investigations, collaborating with end users to resolve issues.
- Train staff on GMP principles, investigations, and root cause analysis.
- Review product records for release of clinical trial materials and components, when required.
- Conduct environmental monitoring and assist with data analysis, when required.
- Conduct audits under the supervision of the Lead Auditor and generate audit reports.
Requirements
- Bachelor’s degree required.
- 5 years of experience in a GXMP or similar regulated environment.
- Experience training users in implementing Quality Systems.
- Prior laboratory experience preferred.
- Experience preparing for external audits and/or site visits.
- Experience reviewing raw materials, supplies, and manufactured products for acceptability.
- Master’s or PhD may substitute for experience, except for validation/technical quality engineering requirements.
- Proficient knowledge of GLP, GMP, and/or GTP.
- Strong leadership, organizational, and time-management skills.
- Ability to train staff effectively.
- High attention to detail in document review.
- Strong interpersonal, verbal, and written communication skills.
- Ability to work independently or collaboratively in a fast-paced environment.
- Adaptability to shift priorities.
- Problem-solving skills and a sense of urgency in completing tasks.
Qualifications
- Education: Bachelor’s degree required.
- Preferred Qualifications: Bachelor’s degree in life sciences or a related field; experience serving as final QA signature for release of raw materials or finished products; experience representing QA in cross-functional settings and reporting back to the department; experience with validation and/or technical quality engineering support of manufacturing operations.
Other Requirements
- Onsite position.
Pay
The anticipated pay range for this position is USD $86,714.00 to USD $140,129.00 per year, based on experience and qualifications.
Benefits
Duke University offers 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/
Equal Opportunity Employer
Duke University is an 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 (including pregnancy and pregnancy-related conditions), sexual orientation, or military status.
Essential Physical Job Functions
Not specified.
Nearest Major Market
Durham
Nearest Secondary Market
Raleigh