Quality Specialist II - cGMP Release & Compliance

Actalent; Plainville (MA); On-site; USD 51,000 - 73,000; Full time

Benefits offered by this job

Medical, dental & vision

5% 401(k) match or similar retirement

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

PTO/Vacation or Sick Leave

Job summary

Actalent, a global engineering and sciences services company, is seeking a Quality Specialist II to support product disposition in a biotech/pharma manufacturing setting. The role emphasizes adherence to cGMP regulations, quality systems, and regulatory requirements, with emphasis on documentation and batch record reviews.

The position involves cross‑functional partnering with Manufacturing, QC, MSAT, Validation, and Regulatory teams to support product release, investigations, CAPAs, and

Qualifications

• Advanced degree with 2+ years or Bachelor's with 3+ years in QA, QC, or GMP biotech/pharma environment
• Degree in Life Sciences, Biology, Microbiology, Biochemistry, Chemistry, Engineering, or related field
• Strong knowledge of cGMPs, batch record review, product disposition, deviations, CAPAs, change controls, and risk assessments
• Experience reviewing analytical, validation, environmental monitoring, and process data to support release decisions
• Familiarity with aseptic manufacturing, upstream/downstream processing, or fill-finish operations preferred
• Experience with TrackWise, Veeva, SAP, LIMS, electronic batch records, and document management systems preferred
• Strong technical writing, problem-solving, communication, and organizational skills

Responsibilities

• Perform batch record review and product disposition for clinical and commercial products
• Review manufacturing, testing, validation, and quality documentation to support product release
• Investigate deviations, support CAPAs, change controls, and risk assessments
• Evaluate product impact using analytical, environmental monitoring, process, and validation data
• Partner with Manufacturing, QC, MSAT, Validation, Supply Chain, and Regulatory teams
• Support audits, inspections, and continuous improvement initiatives

Skills

QA knowledge

cGMP compliance

Analytical thinking

Documentation

Communication

Education

Bachelor's degree in Life Sciences or related field

Advanced degree in Life Sciences or related field

Tools

TrackWise

Veeva

SAP

LIMS

Electronic batch records

Document management systems

Job description

Actalent, a global engineering and sciences services company, is seeking a Quality Specialist II to support product disposition in a biotech/pharma manufacturing setting. The role emphasizes adherence to cGMP regulations, quality systems, and regulatory requirements, with emphasis on documentation and batch record reviews.

The position involves cross‑functional partnering with Manufacturing, QC, MSAT, Validation, and Regulatory teams to support product release, investigations, CAPAs, and