Supervisor; QC Laboratory
CONTRACT PHARMACAL CORP•Town of Smithtown, NY
•Onsite
About The Position
The Supervisor is responsible for assisting the QC Manager with the day-to-day operations for one of the assigned QC laboratories (Raw Material, Finished Product, Microbiology, ICP, Technical Support) which is responsible for the analysis and disposition of commercial materials (raw materials, finished product release, stability, validation, investigation) and environmental samples, as well as any assigned tasks including, but not limited to, troubleshooting, testing assignments, scheduling, training, document review, and special projects.
Requirements
- Bachelor’s degree in a science related field.
- At least 3 years of work experience in a Quality cGMP environment.
- At least 3 years of work experience in a laboratory setting.
- Knowledge of laboratory chemistry or microbiology, and cGMPs.
- Proficient in Microsoft Word, Excel, PowerPoint, graphs/charts and databases.
- Experienced in HPLC/UPLC, ICP, Dissolution, IR, UV/VIS, wet chemistry, and microbial testing.
- Experienced in using analytical software programs, such as Empower.
- Knowledge of laboratory investigations and root cause analysis.
- Skilled in technical writing and data analysis.
- Able to effectively supervise people and give instruction to the department.
- Gowning as required by GMPs and/or SOPs.
Responsibilities
- Follow and ensure that the laboratory follows all laboratory SOPs, including but not limited to laboratory safety, chemical handling and storage, gowning, equipment use, cGMP, GDP, data integrity, DEA requirements, etc.
- Lead person responsible for maintaining and troubleshooting laboratory equipment.
- Assist in training of laboratory personnel.
- Assist in the day-to-day scheduling, assignment, and coordination of testing/release of materials with Operations and Supply Chain.
- Assist in laboratory investigations (OOS, OOT, NCR, Product Complaint).
- Assist in laboratory documentation review for accuracy and completeness according to GMP, GDP, and data integrity requirements.
- Assist in the review and approval of the Certificate of Analysis for material disposition.
- Work with R&D to develop, improve, and transfer analytical methods for testing.
- Assist in the review and approval of specifications, analytical test methods, process and method validation protocols and reports, change controls, etc.
- Assist in testing materials, as needed.
- Coordinate and interact with all outside contract laboratories used for testing of samples.
- Ensure that all laboratory equipment is in a calibrated and qualified state as defined and required by SOPs.
- Assist with Metrology related functions, when needed.
- Other responsibilities as assigned by Senior Management.
- Responsible for supervising nonunion employees.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
501-1,000 employees
