Under minimal supervision, this role performs a wide range of Quality Assurance activities to ensure compliance across manufacturing, facilities, utilities, environmental programs, and quality systems. Responsibilities include review and approval of critical GMP documentation, leading investigations, supporting audits, and providing lot disposition for product release.
Responsibilities
- Review and approve product master records (MPs).
- Approve process validation protocols and reports for manufacturing processes.
- Approve Environmental Characterization reports.
- Approve planned incidents and support incident triage activities.
- Review and approve Work Orders and EMS/BMS alarms.
- Approve nonconformance investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
- Own and maintain site quality program procedures.
- Review and assess risk assessments.
- Lead investigations and ensure timely, compliant closure.
- Lead site audits and support internal/external inspections.
- Evaluate compliance issues using advanced data trending and analysis.
- Serve as designee for QA management on local change control review boards (CCRB).
- Support automation, facilities, and environmental programs.
- Represent QA on New Product Introduction (NPI) teams.
- Collaborate with Manufacturing, Process Development, Validation, Quality Control, Engineering, Facilities, Utilities, and Contractors.
- Coordinate with external resources when higher‑level expertise is required.
- Interact effectively with regulatory agencies.
Requirements
- Doctorate OR
- Master’s + 2 years of directly related experience OR
- Bachelor’s + 4 years of directly related experience OR
- Associate’s + 8 years of directly related experience OR
- High School/GED + 10 years of directly related experience
Preferred Qualifications:
- Experience performing on‑the‑floor Plant Quality Assurance (PQA) activities, including review, approval, and tracking of cGMP processes, procedures, testing methods, batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise.
- Expertise in deviations, CAPAs, change controls, and validation activities.
- Experience with procedural compliance and initiate deviation records during on‑the‑floor triage.
- Experience supporting audits and inspections as part of the audit/inspection management team.
- Experience with computer systems validation or computer systems quality assurance (medical device or consulting background preferred).
- Experience with validation of GxP applications (VMP, IQ, RA/GxP assessment, OQ, PQ, test scripts, summary reports).
- Experience serving as Quality Contact for complex new‑product projects.
- Experience in commissioning and qualification.
- Project management and organizational skills.
Benefits
Shift & Contract Details
- Non‑Standard Shift
- 6‑month contract with possible extension
Skills Required
- Doctorate degree
- Master's degree and 2 years of directly related experience
- Bachelor's degree and 4 years of directly related experience
- Associate's degree and 8 years of directly related experience
- High school diploma or GED and 10 years of directly related experience
- Plant Quality Assurance experience involving cGMP processes, procedures, testing methods, batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise
- Expertise in deviations, CAPAs, change controls, and validation activities
- Experience with procedural compliance and initiating deviation records during on-the-floor triage
- Experience supporting audits and inspections
- Experience with computer systems validation or computer systems quality assurance
- Experience validating GxP applications, including VMP, IQ, risk assessments, OQ, PQ, test scripts, and summary reports
- Experience serving as Quality Contact for complex new-product projects
- Experience in commissioning and qualification
- Project management and organizational skills
What We Do
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results. Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields. We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions. BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
