Job Description

Oversee the qualification of equipment, facilities, utilities, analytical instruments, and computerized systems.

Support qualification and startup activities for large capital projects as a Quality Assurance resource.

Review and approve system lifecycle documentation, including Requirements Specifications, Configuration Specifications, Risk Assessments, IQ/OQ/PQ Protocols, and Summary Reports.

Perform QA review and approval of validation non-conformances.

Collaborate with process owners and SMEs to resolve compliance issues.

Provide QA support for other project-related activities as needed.

detailed review of GMP documents

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

Bachelors degree in engineering or Life Sciences

5+ years of total combined experience in quality assurance and/or validation within a GMP regulated manufacturing environment (FDA, EMA, MHRA

experience providing QA oversight of qualification of equipment, utilities, facilities, and analytical instrumentation and computerized systems

experience in biologics and/or gene therapy manufacturing facilities

eVLMS, eDMS and CMMS Experience with large capital project and facility startup

Experience with QC analytical systems null

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.