Quality Control Analyst II (Stability)

Full-time - Mid Level

Milford, MA

About the position

The QC Analyst II is responsible for conducting routine and non-routine analyses of raw materials, in-process materials and finished products in accordance with cGMP guidelines. The appropriately trained individual may provide training and guidance to other QC Analysts. The individual troubleshoots problems associated with methods and instruments resolving them where possible or seeking guidance/authorization where required.

Responsibilities

• Understands the importance and priority of EHS and takes personal responsibility for their own safety.
• Looks out for the safety of colleagues and avoidance of all incidents; willingly engages in and embraces activities to improve EHS performance in the working environment.
• Conduct a wide variety of routine testing.
• Test and analyze samples in a timely manner in support of project plans in accordance with cGMP guidelines.
• Review data for compliance against specifications and GMP regulations.
• Generate stability reports, and assist in the development of experimental procedures and protocols.
• Assist with developing/revising documentation such as SOP, testing procedures and material specifications.
• Provide training and guidance to other analysts.

Requirements

• BS in chemistry, biology, or related discipline
• 2-5 years' experience as a QC analyst/chemist in a GMP environment
• Experience and familiarity with analytical testing equipment and methodology including HPLC, Karl Fischer, Spectrophotometry (UV/VIS), and LCMS