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Job Description

The QC Analyst In-Process Laboratory position supports the Quality Control In-Process and conducts biochemical, microbiological, and general chemical testing of in-process or final product samples submitted to the QC laboratories. The position requires analytical testing to be completed in compliance with all applicable procedures, standards and GMP regulations. This position requires high attention to detail, organizational leadership, interpersonal skills, a quality mindset, critical thinking, and technical writing skills. This position will be the shift leader and primarily work independently.

Key Responsibilities:

-Perform analytical testing in compliance with applicable GMP regulations while maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations.

-Conduct biochemical, microbiological, and/or general chemical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.

-Perform peer review of laboratory data

-Utilize electronic systems i.e. LIMS, MES, LES, Empower, Trackwise, etc. for execution and documentation of testing

-Maintain Laboratory Housekeeping including: sample management, reagent prep, instrument standardization/calibration

-Complete Document Revisions

-Maintain individual training completion in a compliant state and train new laboratory personnel

-Participate in continuous improvement

-Execute CAPAs when required for the Quality Control organization

-Maintain Laboratory in audit ready state and participate in internal and Health Authority inspections

-Provide input to functional laboratory meetings

-Ability to work independently on an alternative shift and communicate with operations staff

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Skills and Requirements

-A minimum of a bachelors degree in chemistry, or a Scientific related field

-Minimum 1 year of working in current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems

-Knowledge and awareness of compendial requirements and standards for QC testing

-Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols -2+ years of working in current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems

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We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.