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Quality Control Laboratory Supervisor

National Recruiting Group

This is a Contract position in Suffolk County, NY posted March 25, 2020.

Performs general to moderately technical chemist duties in testing of full product line, raw materials, finished product, compliant stability and process validation samples, performs complex analytical procedures, completes pertinent documentation associated with testing and performs related duties as assigned.

A biopharmaceutical company specializing in the development, production and distribution of plasma-derived products.

Main Responsibilities: Operates, maintains and troubleshoots all laboratory equipment, solves analytical problems that involve troubleshooting equipment and laboratory method, and reports method issues to Supervisor.

Operates general analytical instruments for all routine testing (i.e., HPLC, GC, UV and IR) Performs USP/EP monograph release testing on incoming raw materials Performs wet chemistry tests (i.e., LOD, pH, titration, etc.).

Labels, transcribes and records data on approved report sheets, maintains appropriate documentation (records and lab notebooks) of tests and assays, and performs all necessary calculations associated with test analysis as required by SOP’s Reviews and audits analytical data from other laboratory personnel.

Complies with good housekeeping and safety practices; ensures the collection and proper disposal of hazardous waste from laboratory instruments.

Participates in troubleshooting of analytical test methods and laboratory instruments.

Performs related duties as assigned.

Knowledge, Skills & Technical Expertise: Should have understanding of Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.

Demonstrated capability with instrumentation, Spectroscopic techniques and chromatographic systems such as UV/IR, HPLC and GC.

Demonstrated understanding and ability to apply concepts of Analytical chemistry.

Demonstrated skill and understanding of use of Computer applications and programs related to laboratory applications (e.g., HPLC, FTIR, UV/VIS and GC).

Demonstrated capability with Sampling methods and quality control systems.

Ability to apply Quantitative and qualitative techniques and math including statistics.

Demonstrated capability to properly apply Sample preparation techniques.

Supervision: Work under general supervision to meet company goal Measurement of Performance: Maintain a Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team Demonstrate consistent Timeliness and accuracy in completion of projects and paperwork (quantity of work) Demonstrated contribution to projects beyond general responsibilities (quality of work), as assigned.

Ability to identify problem areas affecting operations (knowledge/problem solving) and communicate to proper resource for resolution Contributes to improvement of assigned activities, Offers suggestions for correcting problems and for improving operations Exercises good judgment in dealing with operational problems, resolving where appropriate, escalating where necessary Demonstration of improved Understanding of theory, rationale behind tasks performed Demonstrated understanding and adherence to Kedrion policies, safety procedures and the cGMPs Ability to contribute in a team-oriented environment under very dynamic conditions Qualifications: Bachelors of Science in Chemistry or related science and a minimum of two (2) – five (5) years of related laboratory experience in the pharmaceutical industry; or an equivalent combination of training and experience.

Demonstrated knowledge of industry practices.

Skilled use of Microsoft Word and Excel Knowledge of TrackWise preferred