cGMP Quality Data Reviewer

jobr.pro; Milford (MA); On-site; USD 90,000 - 110,000; Full time

Job summary

Rentschler Biopharma SE in Milford, MA, seeks a Data Reviewer to join the Milford Quality Control team. You will review and approve cGMP analytical data, support product release, and ensure data integrity across laboratory documentation.

This on-site role requires a B.S. in a relevant science, 3+ years in a cGMP lab, and experience with LIMS/EMPOWER and analytical instruments. Strong communication, teamwork, and the ability to prioritize tight timelines are essential.

Qualifications

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

Responsibilities

• Review and approval of cGMP analytical data comparing results to specifications and SOPs.
• Collaborate with QC and cross-functional teams to resolve quality issues.
• Support Product Release activities and timelines.
• Identify and resolve data integrity issues with guidance from Data Review team.
• Create or revise SOPs and test forms as needed.
• Assist/train new hires on cGMP/GDP.

Skills

cGMP experience

Analytical thinking

Strong communication

Teamwork

Education

B.S. in Chemistry/Biology/Chemical Engineering or related sciences

Tools

LIMS

EMPOWER

HPLC

PA800

CS2500

SDS-PAGE

Job description

Rentschler Biopharma SE in Milford, MA, seeks a Data Reviewer to join the Milford Quality Control team. You will review and approve cGMP analytical data, support product release, and ensure data integrity across laboratory documentation.

This on-site role requires a B.S. in a relevant science, 3+ years in a cGMP lab, and experience with LIMS/EMPOWER and analytical instruments. Strong communication, teamwork, and the ability to prioritize tight timelines are essential.