QC Chemist

Job Description

Job Description:
Perform accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines. Completes second person verification of test results. Participates in laboratory root cause investigations and quality system improvement initiates by executing well defined protocols and procedures. Shares technical information and best practice within the group. 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 Analysis. Sample preparation, instrument set-up and operation, data entry, primary data review. Coordination of method transfers and co-validations. Qualifying, calibrating, and maintaining analytical instrumentation. 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.

Request preferences / nice to haves:

Fundamental knowledge of cGMP compliance requirements, instrument qualification procedures and computer system validation principles. Good documentation skills and ability to author and/or review standards, guidelines, SOPs, templates, protocols, and other GMP documentation. Excellent general computer skills (MS Excel, Word, etc.) and the ability to compile summarize and present information to a diverse group. Excellent communication skills and willingness to interact with laboratory personnel, contractors and management. Ability to troubleshoot problems and identify solutions. Ability to influence and partner with individuals both within and outside of a formal reporting relationship towards realization of team goals. Assist in addressing laboratory investigations within specified timeframe.

Primary Position Responsibilities (major or daily tasks):

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. Promote elimination of problems by identifying and addressing root cause.

Qualifications

Request preferences / nice to haves:

Fundamental knowledge of cGMP compliance requirements, instrument qualification  procedures and computer system validation principles. Good documentation skills and ability to author and/or review standards, guidelines, SOPs, templates, protocols, and other GMP documentation. Excellent general  computer skills (MS Excel, Word, etc.) and the ability to compile  summarize and present information to a diverse group. Excellent communication skills and willingness to interact with laboratory personnel, contractors and management. Ability to troubleshoot problems and identify solutions. Ability to influence and partner with individuals both within and outside of a formal reporting relationship towards realization of team goals. Assist in addressing laboratory investigations within specified timeframe.

Additional Information

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