QC Analyst II - Stability & Release Expert

Rentschler Biopharma Inc.; United States; On-site; USD 111,750,912 - 131,808,768; Full time

Job summary

Rentschler Biopharma, Inc. in Milford, MA is seeking a Quality Control Analyst II for Release and Stability Testing. You will perform analytical testing, ensure GMP compliance, and collaborate with QC and cross-functional teams to resolve quality issues.

The ideal candidate has a life sciences degree and 3+ years in a cGMP lab, with hands-on experience in Empower chromatography software and analytical methods. On-site position with potential weekend/testing as required.

Qualifications

• Bachelor's Degree in Life Sciences discipline.
• Minimum 3+ years’ experience in a cGMP analytical lab environment.
• Self-starting, motivated, and organized with strong time management and adaptability.

Responsibilities

• Perform analytical testing using HPLC/UPLC/cGE/icIEF instruments following GMP documents.
• Create/revise SOPs, Protocols and Reports.
• Practice safe work habits and adhere to safety procedures and guidelines.
• Perform maintenance and cleaning of laboratory equipment.
• Support SME in OOS/OOT investigations, deviations, change controls, CAPA to prevent non-conformances.
• Update and track metrics for trending and reporting; stability and QC data.
• Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems.
• Exceptional communication and interpersonal skills.
• Assists in training of new hires and retraining of QC staff.

Skills

cGMP analytical lab

Time management

Communication across diverse groups

Self-starting

Education

Bachelor's Degree in Life Sciences discipline

Tools

HPLC/UPLC/cGE/icIEF

Job description

Rentschler Biopharma, Inc. in Milford, MA is seeking a Quality Control Analyst II for Release and Stability Testing. You will perform analytical testing, ensure GMP compliance, and collaborate with QC and cross-functional teams to resolve quality issues.

The ideal candidate has a life sciences degree and 3+ years in a cGMP lab, with hands-on experience in Empower chromatography software and analytical methods. On-site position with potential weekend/testing as required.