Specialist QA

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