QC Analyst II - (Weekends) in Cambridge

Shift: Day Shift, Friday- Monday, 7:00am - 5:30pm

Vacancy Status: This position is currently vacant

AI Disclosure in Hiring: We do not use artificial intelligence to screen, assess, or select applicants

Job Summary

Reporting to the Quality Control Project Lead, the QC Analyst II is responsible for the analysis of raw materials, in-process, finished products and stability samples using various wet chemistry and instrumentation techniques to assure compliance to cGMP, SOPs and Bimeda quality standards. The position also provides testing support for the Stability Program. The QC Analyst II is experienced with all types of laboratory equipment and can troubleshoot common instrumentation issues and provide guidance to junior QC Analysts.

Responsibilities

• Conduct all analytical (physical & chemical) testing of raw materials, in-process samples, finished products, gases, water and stability program samples (e.g., pH, conductivity, TOC, viscosity, potency and impurity tests).
• Review data, results and documentation for QC analytical testing.
• Ensure that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
• Prepare samples for analysis according to company methods, SOPs & applicable compendia (USP/EP).
• Perform specific analytical tests utilizing HPLC, GC, UV, IR, FTIR, KF and other instruments.
• Document analytical test results in logbooks and in-process test data in Production dockets as required.
• Analyze data and keep the supervisor informed of discrepancies, deviations, out-of-specification (OOS) data, and unusual trends as they occur.
• Assist with quality investigations as required.
• Ensure that reagents and supplies are replenished by informing the QC Supervisor or preparing PO requisitions when required.
• Perform calibration of equipment, troubleshoot issues and ensure equipment is in good working order, including arranging repairs when needed with outside vendors.
• Support and provide training and guidance to junior analysts.
• Ensure work areas are kept clean and tidy and clean glassware after use when required.
• Perform other duties as assigned.

Requirements

• 3–5 years in a pharmaceutical analytical testing laboratory and supporting stability programs.
• B.Sc. in Chemistry, Biochemistry or related discipline.
• Analytical wet chemistry laboratory experience using titration, pH, potency, conductivity, viscosity, TOC, UV, IR, GC, HPLC assays.

Benefits

• Competitive vacation policy effective upon hire.
• 13 paid holidays.
• 5 paid personal care days.
• Medical, dental, vision, STD & LTD benefits.
• Defined contribution pension plan with employer matching 5 %.
• Employee Assistance Program.

Expected salary range: $55,000 – $65,000 K / year, DOE.

Core Behaviors, Skills & Abilities

• Thoroughness / Detail oriented – ensuring completeness and accuracy of work, preparing for meetings and presentations, and following up to ensure commitments are met.
• Integrity / Personal credibility – demonstrating responsibility, reliability and trustworthiness.
• Analytical thinking / problem solving – identifying information needed to clarify situations, seeking information, tackling problems logically, and interpreting data to identify patterns, trends and cause‑effect relationships.
• Change agility / adaptability – supporting innovation and organizational change, embracing change, and striving for continuous improvement.
• Fostering collaboration / teamwork – working jointly with others, building partnerships, and respecting colleagues.