cGMP QA Lab Analyst – CAPA & Investigations

Actalent; Dayton (OH); In loco; USD 34.000 - 37.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Time Off/Leave (PTO)

Descrizione del lavoro

Actalent is hiring a Quality Specialist to support QA and QC in a regenerative medicine laboratory and manufacturing setting. The role focuses on documentation review, investigations, CAPA management, deviation tracking, and compliance with established regulations and GDP.

You will work with cross-functional teams to ensure batch release readiness and maintain cGMP documentation, while participating in audits and training activities in a fully onsite Dayton, OH environment.

Competenze

• 6+ months of experience in a regulated laboratory, manufacturing, quality, or similar highly regulated environment.
• Experience with quality systems, CAPAs, deviations, investigations, NCRs, or document control processes is preferred.

Mansioni

• Review batch records and manufacturing documentation for lot release.
• Coordinate CAPAs, NCRs, and deviation records with timely completion and follow-up.
• Support investigations and root-cause analyses for quality events and process improvements.
• Coordinate environmental monitoring programs and related documentation.
• Assist with development, review, and release of environmental monitoring trend reports.
• Provide support for batch release requirements and quality compliance processes.
• Support QMS activities across cGMP departments.
• Perform QC activities including incoming, in-process, and finished product inspections.
• Inspect medical devices, tissue-based products, raw materials, and labeling for quality.
• Maintain thorough documentation per GDP.
• Support gowning qualification programs and training.
• Review microbiology and environmental monitoring test results.
• Collaborate on CAPA implementations for recurring quality concerns.
• Assist with equipment qualification reviews, calibration docs, and preventive maintenance.
• Participate in regulatory inspections, customer audits, and internal audits.

Conoscenze

Laboratory experience

Regulatory awareness

Formazione

Bachelor's degree in Biology, Chemistry, Microbiology, Biochemistry, or related field

Descrizione del lavoro

Actalent is hiring a Quality Specialist to support QA and QC in a regenerative medicine laboratory and manufacturing setting. The role focuses on documentation review, investigations, CAPA management, deviation tracking, and compliance with established regulations and GDP.

You will work with cross-functional teams to ensure batch release readiness and maintain cGMP documentation, while participating in audits and training activities in a fully onsite Dayton, OH environment.