Job Opening - QC Group Leader - 2nd Shift
G & W Labs - South Plainfield, NJ

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Job Opening - QC Group Leader - 2nd Shift

Basic Function and Responsibility:

Independently oversee the activities of junior level personnel

Timely releases of raw material, in process, process validation, finished products

Ensure that data generated by the chemists is accurate and precise

Ensure that the laboratory operation and activities are in compliance with cGMP, CFR, FDA, SOPs and safety guidelines

Troubleshoot wide range of technical problems

Maintain laboratory equipment in good working conditions and documents in orderly manner

Monitor the purified water system and ensure to meet the USP Standard

Work Performed:

Works on new assignments and creates QC Testing Team schedules

Reviews documentation of laboratory deviations, laboratory errors, OOS investigations and OOT investigations

Proposes effective CAPA's for investigations and deviations

Oversees and reviews release-testing results for in-process and finished products for compliance with CGMP's

Ensure CGMP compliance of all activities performed

Represents QC Chemistry in internal and external audits as required

Creates Certificates of Analysis for in-process and finished goods as needed

Instrument troubleshooting

Provide guidance and training to junior staff for the respective job function assigned

Maintain and evaluate training records on semi-annual basis

Performs testing and other duties as assigned

Aspects of Performance:

Maintains confidentiality

Possesses sound analytical problem-solving and documentation skills

Demonstrates ability to prioritize conflicting demands

Executes assigned tasks within established schedule

Writes and speaks clearly and concisely

Develops and maintain expertise in chemistry/pharmaceutics through continuing professional education and training

Comply with Company policies, procedures, rules and cGMP regulations Education:

Minimum of BS degree in Chemistry or related field Experience:

Minimum of seven years in analytical testing preferably in pharmaceutical QC environment

Please provide salary requirements to be considered for this position.

G & W Labs - 2 years ago - save job