QC Analyst II - 3rd 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. Quality Control Analyst II is experienced with all types of laboratory equipment and can troubleshoot common instrumentation issues and provide guidance to junior QC Analysts and Technicians.

• 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.

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

EFFECTIVE COMMUNICATION – Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen and show respect for oneself and others in interactions with others.

Express oneself clearly in verbal and business writing.

EXECUTION/ACCOUNTABILITY – A willingness to accept responsibility or to account for one’s actions. Accountability is when an individualor a department experiences consequences for their performance or actions.

CHANGE AGILITY/ADAPTABILITY –The ability to demonstrate support for innovation and for organizational changes needed to improve the organization’s effectiveness, initiating, sponsoring, and implementing organizational change. The ability to change or be changed in order to fit or work better on some situation or purpose and embraces change. Strives for continuous improvement.

ANALYTICAL THINKING/PROBLEM SOLVING - I s the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this .

THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled .

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