OPERATIONS LEAD II, ELECTROPHORESIS(Job Number: 1203655)
The QC Operations Lead is responsible for leading the scheduling and review, as well as other day-to-day compliance and operational activities in the Electrophoresis testing group within Syracuse Quality Control. The primary goals of the position are to meet established test cycle attainment times and other quality metrics (e.g. shop floor compliance) as well as improve laboratory efficiency through effective scheduling of personnel, instruments, and samples. The QC Operations Lead will assure laboratory duties are performed in accordance with cGMP regulations, corporate policies & directives, site and departmental procedures. Additionally, the QC Operations lead will perform routine QC testing when required by peaks in test sample volumes.
- Coordinate activities related to the testing of release, stability, and in process samples. This includes scheduling of samples, personnel, and equipment. •Perform data analysis, review and authorization of results •Write and conduct laboratory investigations. •Support internal/external audits. •Lead safety and compliance activities within the department •Ensure laboratory instrument/equipment maintenance, cleaning, performance checks and calibrations are performed & reviewed as required. •Provide recommendations to management on compliance and operational improvements in the laboratory, and drive improvements. •Write/modify/review SOP’s or act as approval designee as required. •Verify the analysts are trained and comply with operating procedures to meet all cGMP and safety requirements. •Perform cGMP testing of release & stability samples when required by high test demand
To be considered for the position, the successful candidate must possess the following: •BS degree in scientific area with a minimum of 7-9 years experience, MS with 3-6 years experience or PhD with a minimum of 0-2 years experience working in the bio/pharmaceutical industry. •Sufficient analytical skills and experience with bioanalytical methods (assay development, QC testing, etc.) to perform routine testing. •Strong working knowledge and experience with cGMPs in a laboratory setting. •Strong interpersonal, oral and written communication skills. •Proven ability to build a team based, collaborative environment promoting candor, clarity of purpose and high commitment to business goals •Exceptional organizational and time management skills •Proven ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.
Job Function: Quality
Primary Location: NA-US-NY-Syracuse
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