As a Pharmaceutical Quality Control Lead, your responsibilities will include:
Keeping work area clean and maintaining a safe work environment.
Performing analytical testing of USP and NF products to their respective monographs. Testing samples are to be collected and tested timely and stored as required.
Providing ongoing API technical support to all shift laboratory technicians.
Responsible for the operation, maintenance, repair and trouble-shooting of API laboratory instrumentation including FTIR, Atomic Absorption (AA), and HPLC.
Ordering laboratory supplies including instrumentation, chemicals, glassware and various testing supplies. Evaluating suppliers for cooperation, timeliness in response and competitive pricing.
Maintaining complete, accurate and legible test records, in accordance with Company policy and record keeping procedure and ensuring all laboratory data is accurate and reliable.
Analyzing, evaluating and providing recommendations on the API laboratory procedures.
Performing method and instrumentation validations as necessary maintaining the validated state of the laboratory.
Updating and creating new procedures as needed.
Providing back-up coverage for technician testing of both in-process and final product
Aiding in API laboratory Out of Specification (OOS) investigations to ensure that the investigations are thorough, timely, unbiased, well-documented, and scientifically sound and inline with FDA’s guidance for OOS investigations. Conducting and/or implementing any necessary Corrective Action to prevent reoccurrence
Performing other work as assigned by laboratory management.
Providing weekend/holiday laboratory coverage as needed.
The Quality Control Lead position is well-suited for you if you have:
Experience working in a Quality Control Laboratory in the pharmaceutical industry, required.
Experience following all safety and quality guidelines according to Good Laboratory Practices and lab safety requirements for laboratory that performs testing of an API.
Capacity to solve problems through creative, innovative solutions and challenge traditional methods of accomplishing tasks.
Ability to build consensus and foster positive relationships.
Worked as part of a technical group in a diverse work environment to accomplish a common goal.
Ability to learn and apply Ingredion’s Safety, GMP, Quality and Continuous Improvement standards.
Qualified candidates will have:
Bachelor’s degree in chemistry, or similar technical degree.
Possess good working knowledge of pharmaceutical laboratory practices. Minimum 5 years’ experience working in a laboratory in the pharmaceutical industry.
Familiarity with SAP, a plus.
Experience with Waters Empower, Thermo Fisher OMNIC Software, and Perkin Elmer Syngystix software, a plus.
Demonstrated experience operating, maintaining, and repairing API laboratory instrumentation such as FTIR, AA, and HPLC.
Strong written and verbal communication skills. Ability to communicate across functional lines at all levels.
Decision making ability, planning and time management skills.
Initiative; be a self-starter and takes responsibility for personal actions, decisions and results.
Job ID: 42213
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