Pharmaceutical QA/QC Senior SpecialistEurofins PSS Insourcing Solutions • United States
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Pharmaceutical QA/QC Senior Specialist
Eurofins PSS Insourcing Solutions
- United States
- United States
À propos
This role is located in Sanford, NC. Position Responsibilities:
Review and approve QA documentation, including validation protocols, method transfers, and compendial assessments. Provide final QA approval for change controls, CAPAs, deviations, and lab investigations (OOS/OOT/OOE). Support electronic record reviews and compendial change documentation. Make real-time quality decisions in compliance with cGMP and regulatory standards. Collaborate cross-functionally to resolve technical and quality issues. Contribute to start-up activities and perform additional QA duties as needed. Qualifications:
Bachelor's or Master's Degree in Microbiology, Chemistry, Pharmaceuticals, or related field. Experience requirements vary: Bachelor's degree with 6-8 years, Master's degree with 4-6 years. Experience in a cGMP microbiology lab is required, with familiarity with USP, JP, and EMEA standards. Strong understanding of data integrity, root cause analysis, and quality systems. Prior QA experience supporting QC documentation investigations. Effective team player with strong communication and problem-solving skills. Additional requirements include a valid drivers license, personal transportation, and authorization to work indefinitely in the US. Additional Information:
This is a full-time position, Monday-Friday, 8 am-5 pm. Candidates living near Sanford, NC are encouraged to apply. Benefits include medical, dental, vision, life and disability insurance, 401(k) with company match, paid vacation, and holidays. Eurofins USA PSS Insourcing Solutions is an Equal Employment Opportunity employer, supporting disabled and veteran applicants. Other Details:
Seniority level: Mid-Senior level Employment type: Full-time Job function: Production
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Compétences linguistiques
- English
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