QC Analyst II Weekends

Position: QC Analyst II - (Weekends)
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. This 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 compliance with company safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
Prepare samples for analysis according to company methods, SOPs and 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.
Assist with quality investigations as required.
Ensure reagents and supplies are replenished, informing the QC Supervisor or preparing purchase order requisitions when required.
Perform calibration of equipment, troubleshoot issues and ensure equipment is in good working order, including arranging repairs with outside vendors when needed.
Support and provide training and guidance to junior analysts.
Maintain clean and tidy work areas, cleaning glassware after use when required.
Provide independent oversight on the production floor, verifying that manufacturing activities are performed in accordance with approved procedures, specifications and regulatory expectations (including line clearance activities, in‑process and final QA checks, AQL checks and support for failure events).
Other duties as assigned.
Requirements   3–5 years in a Pharmaceutical Analytical testing laboratory supporting stability programs.
B.Sc. in Chemistry, Biochemistry or related discipline.
Analytical Wet Chemistry Lab experience with methods such as titration, pH, potency, conductivity, viscosity, TOC, UV, IR, GC, HPLC assays.
Compensation & 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 per year, DOE.
Core Behaviors, Skills & Abilities   Thoroughness / Detail Oriented – ensuring work is complete, accurate and follows procedures.
Integrity / Personal Credibility – reliable, trustworthy and responsible.
Analytical Thinking / Problem Solving – identify necessary information, analyze data, spot patterns and deduce causes.
Change Agility / Adaptability – support innovation and organizational change, embrace continuous improvement.
Fostering Collaboration / Teamwork – work cooperatively, lead teams, build partnerships, respect others.

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