QC Analyst II - 3rd Shift

Bimeda•Le Sueur, MN

1d•Onsite

About The Position

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 Quality Control Analyst II is experienced with all types of laboratory equipment, can troubleshoot common instrumentation issues, and provide guidance to junior QC Analysts and Technicians.

Requirements

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 the following methods/equipment: 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 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

Responsibilities

Conducts all analytical (physical & chemical) testing of raw materials, in-process samples, finished products, gases, water, and stability program samples. i.e., pH, conductivity, TOC, viscosity, potency tests
Reviews data, results, and documentation for QC analytical testing.
Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP), and Standard Operating Procedures (SOPs).
Prepares samples for analysis according to company methods, SOPs, & applicable compendia (USP/EP).
Performs specific analytical tests utilizing HPLC, GC, UV, IR, FTIR, KF, and other instruments.
Documents analytical test results as they occur in logbooks and in-process test data in production dockets as required.
Analyzes data; keeping the supervisor informed of discrepancies, deviations, out-of-specifications (OOS) data and unusual trends as they occur.
Assists with quality investigations as required.
Ensures that reagents and supplies are replenished by informing QC Manager or QC Coordinator or preparing PO requisitions when required.
Performs calibration of equipment, troubleshooting issues, and ensuring equipment is in good working order including arranging repairs when needed with outside vendors.
Supports and provides training and guidance to junior Analysts and Technicians.
Ensures that work areas are kept clean and tidy and cleans glassware after use when required.