QC Lab Tech/Chemist

Perform accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines. Participates in laboratory root cause investigations and quality system improvement initiates by executing well defined protocols and procedures. Design and evaluation of experiments, methods development and characterization, support of process development/optimization and the analysis and interpretation of data. Conduct studies to validate methods, develop methods, evaluate new technologies. Sample preparation, instrument set-up and operation, data entry, primary data review. All laboratory work will be conducted and documented in accordance with the appropriate Quality System. Act as a resource for insuring adherence to quality systems.

Fundamental knowledge of cGMP compliance requirements, instrument qualification procedures and computer system validation principles. Excellent general computer skills (MS Excel, Word, etc.) Excellent communication skills and willingness to interact with laboratory personnel, contractors and management. Assist in addressing laboratory investigations within specified timeframe.

Perform analytical and physical testing on in-process, finished product and stability samples. Assist laboratory leader in ensuring compliance with all procedures, safety and regulatory commitments in Quality Control. Perform review and approval of analytical data. Maintain analytical methods in the laboratory in a state of validation. Assist in addressing laboratory investigations within specified timeframe. Fundamental knowledge of cGMP compliance requirements, instrument qualification procedures and computer system validation principles. Excellent general computer skills (MS Excel, Word, etc.) Excellent communication skills and willingness to interact with laboratory personnel, contractors and management. Assist in addressing laboratory investigations within specified timeframe.

All your information will be kept confidential according to EEO guidelines.

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