Quality Control Data Reviewer – cGMP & Data Integrity

Rentschler Biopharma; Milford (CT); On-site; USD 90,000 - 110,000; Full time

Job summary

Rentschler Biopharma in Milford, MA, seeks a Data Reviewer to perform cGMP analytical data review in the QC lab. You will assess analysis results, support product release, and ensure data integrity in a fast-paced environment.

Ideal candidates have a B.S. in a biological science and 3+ years in a cGMP lab, with HPLC and LIMS/EMPOWER experience. This is an on-site role requiring strong attention to detail and collaboration.

Qualifications

• B.S. in Chemistry, Biology, Chemical Engineering, or related biological sciences.
• 3+ years in a cGMP analytical laboratory environment.
• HPLC, PA800, CS2500, SDS Page.
• LIMS, EMPOWER.
• cGMP experience.

Responsibilities

• Review and approve cGMP analytical data to ensure accuracy and quality.
• Collaborate with QC and cross-functional teams to resolve quality issues.
• Support product release activities and ensure timelines are met.
• Handle diverse data problems requiring analysis of identifiable factors.
• Identify and resolve issues with guidance from Data Review team.
• Review LIRs and support data integrity initiatives.
• Provide timely status updates to management.
• Assist in training and mentoring QC staff on cGMP/GDP.

Skills

Attention to detail

Quality-conscious

Strong communication

Education

B.S. in Chemistry, Biology, Chemical Engineering, or related biological sciences

Tools

LIMS

EMPOWER

Job description

Rentschler Biopharma in Milford, MA, seeks a Data Reviewer to perform cGMP analytical data review in the QC lab. You will assess analysis results, support product release, and ensure data integrity in a fast-paced environment.

Ideal candidates have a B.S. in a biological science and 3+ years in a cGMP lab, with HPLC and LIMS/EMPOWER experience. This is an on-site role requiring strong attention to detail and collaboration.