QC Analyst II – Release & Stability (cGMP)

Rentschler Biopharma; United States; On-site; USD 75,000 - 102,000; Full time

Job summary

Rentschler Biopharma is seeking a Quality Control Analyst II, Release and Stability Testing, to perform cGMP analytical testing on stability samples and evaluate data to ensure compliance with protocols and GLP/cGMP guidelines. The role requires working independently within defined windows and collaborating with QC and cross-functional teams to resolve quality issues.

The position is on site in Milford, MA, with a focus on timely release of medicines.

Qualifications

• Bachelor's Degree in Life Sciences discipline.
• Minimum 3+ years' experience in a cGMP analytical lab environment.
• Self-starting motivated person who possesses excellent time management, the ability to adapt to change and organizational skills.
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a collaborative, comprehensible and reasonable manner.
• Able to use and learn standard office equipment and technology with proficiency.
• Experience in Empower chromatography software.

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.
• SME to support or lead investigations related to OOS/OOT deviations, change controls, corrective actions, and preventive actions.
• Update and track metrics for trending and reporting; stability and QC analytical data.
• Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems.
• Assists in training of new hires and retraining of QC laboratory staff.

Skills

cGMP knowledge

Time management

Adaptability

Communication

Laboratory testing

Education

Bachelor's Degree in Life Sciences

Tools

Empower chromatography software

Job description

Rentschler Biopharma is seeking a Quality Control Analyst II, Release and Stability Testing, to perform cGMP analytical testing on stability samples and evaluate data to ensure compliance with protocols and GLP/cGMP guidelines. The role requires working independently within defined windows and collaborating with QC and cross-functional teams to resolve quality issues.

The position is on site in Milford, MA, with a focus on timely release of medicines.