QC Analyst II - Day Shift

Reporting to the Quality Control Manager, 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, can troubleshoot common instrumentation issues and provides guidance to junior QC Analysts and Technicians.

• 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 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, 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; keep the supervisor informed of discrepancies, deviations, out‑of‑specifications (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 Manager or QC Coordinator 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 and technicians.
• Ensure that work areas are kept clean and tidy and glassware is cleaned after use when required.

Effective communication – the ability to convey information clearly and efficiently, listen actively, and facilitate information sharing between people.

Execution/accountability – willingness to accept responsibility and account for actions, with an understanding of the consequences of performance.

Change agility/adaptability – ability to support innovation and organizational changes, initiate and sponsor change, and embrace continuous improvement.

Analytical thinking/problem solving – ability to identify needed information, seek it from various sources, and tackle problems with a logical, systematic approach, spotting patterns and deducing cause and effect.

Thoroughness/detail oriented – ensuring own and others’ work and information are complete and accurate, preparing for meetings and presentations, and following up to fulfill agreements and commitments.

• 2-4 years in a pharmaceutical analytical testing lab supporting stability programs.
• B.Sc. in Chemistry, Biochemistry, or related discipline.
• Analytical wet chemistry lab experience using titration, pH, potency, conductivity, viscosity, TOC, UV, IR, GC, HPLC assays.
• High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize work in a team environment and individually, and take initiative.
• Strong problem identification and problem resolution skills.
• High level of proficiency with Microsoft Office.
• Excellent written and verbal communication skills for liaising and communicating with internal departments and external vendors.
• Strong work ethic and positive team attitude.

• 401(k) plan for retirement savings.
• Paid time off (vacation, sick leave, holidays).
• Life insurance.
• Employee assistance program.

Bimeda is an equal opportunity employer committed to fostering a diverse workforce. All qualified applicants will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.