Senior QA Specialist

Benefits

Additional Information

Lead and perform deviation and investigation writing/review , including thorough root cause analysis and CAPA development/effectiveness checks Review and approve quality agreements and ensure alignment with regulatory and client requirements Host and support external audits , including regulatory agency inspections and client audits Conduct internal audits, walkthrough inspections , and ensure audit readiness across laboratory operations Perform and support risk assessments to proactively identify and mitigate quality risks Drive data integrity compliance initiatives, ensuring adherence to ALCOA+ principles Manage and support change control processes , ensuring impact assessments and compliance with procedures Review and approve SOPs, analytical methods, protocols, and reports Release and ensure accuracy of analytical reports Contribute to monthly and quarterly quality metrics reporting Identify and implement continuous improvement opportunities within QA and laboratory functions Partner cross-functionally with laboratory staff, clients, and leadership to ensure quality objectives are met Maintain a strong commitment to safe, compliant, and efficient operations Bachelor's degree in Chemistry, Biology, Biochemistry , or related scientific discipline 4+ years of QA experience within a pharmaceutical or regulated laboratory environment Proven experience with: Investigations and CAPA management Audit hosting (client and/or regulatory) Quality systems (change control, deviations, document control) Data integrity principles and compliance expectations Strong working knowledge of GxP (GMP/GLP) regulations Excellent written and verbal communication skills Ability to confidently interact with clients, auditors, and internal stakeholders Proficiency in Microsoft Office (Excel, Word, PowerPoint) Authorization to work in the U.S. without sponsorship Position is full time, Monday to Friday, 8AM - 5PM. Candidates currently living within a commutable distance of Portage, MI are encouraged to apply. Excellent full time benefits including Comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

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