QC Analyst II

Sanofi • Framingham, MA

73d • $30 - $41

About The Position

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Quality Control department supports the Seprafilm (medical device) and Sodium Hyaluronate (active pharmaceutical ingredient) GMP operations at the 74/76 NYA Manufacturing Facility. The department performs analytical testing on intermediate, inprocess and final product materials using a variety of equipment to include GC, FTIR, UV VIS, and physical property instrumentation. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible.

Requirements

• Bachelor’s degree in Life Sciences or equivalent (Chem, Bio, Microbio, etc)
• 2-5 years lab experience.

Nice To Haves

• Experience in laboratory techniques such as: pH, GC, UV/VIS and FTIR.
• Experience in GMP laboratory as well as technical writing.
• Strong attention to detail and ability to multitask.

Responsibilities

• Supports Biosurgery Business by performing in-process, stability and release testing for Biosurgery Product lines.
• Perform Assays in accordance with SOPs for release, stability and in-process samples.
• Review peer data including data transcription, data calculation and log entries.
• Lab general duties including cleaning, glassware, washing, etc.
• Initiate DCR when assigned.
• Train on all documents assigned to training plan and complete training as assigned.
• Receive, verify and log incoming samples.
• Perform or participate in Equipment Qualifications.
• Perform or participate in Method Validations.
• Participate in audits.
• Complete training as assigned.
• Author technical reports.
• Bring in new equipment (spec, URS, etc.)
• Perform PM or calibration on lab equipment.
• Conduct safety and weekly compliance walkthroughs.
• Responsible for adherence to policies, procedures and SOPs.
• Participate in Lab Investigations.
• Perform OOS investigations as Analyst.
• Adhere to Site Quality and Safety Policies.
• Work toward accomplishment of Site Goals.
• Initiate and help investigate deviations through Trackwise.
• QC testing of in-process, stability and release samples in a GMP lab.
• Troubleshooting of assay/equipment issues.

Benefits

• High-quality healthcare
• Prevention and wellness programs
• At least 14 weeks’ gender-neutral parental leave

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees