Join Our Team as a Quality Assurance Specialist in Wilson, NC!
Are you ready to take the next step in your career with an industry leader in the biotherapeutic and pharmaceutical sector? Located in the vibrant city of Wilson, North Carolina, Janseen Biotech, Inc is seeking a dedicated Quality Assurance Specialist to ensure compliance with regulatory standards and company policies. This role offers the opportunity to collaborate with cross-functional teams and contribute to cutting-edge projects.
Essential Job Duties and Responsibilities
- Ensure compliance with regulatory requirements and company policies, following Good Manufacturing Practices and Pharmaceutical Policies.
- Develop and maintain the site validation program in compliance with all regulatory and corporate requirements.
- Review and approve commissioning and qualification documentation, including URS, IQ, OQ, and PQ protocols and reports.
- Provide quality oversight for C&Q/CSV and validation execution activities to ensure compliance with GMP, FDA, EMA, and other regulatory requirements.
- Support the development and implementation of C&Q and validation plans, ensuring alignment with project timelines and deliverables.
- Act as the QA point of contact for deviations, CAPAs, and change controls related to C&Q and validation activities.
- Collaborate with cross-functional teams to address quality issues and provide recommendations for process improvements.
Requirements
- Bachelor's degree in a scientific or engineering discipline.
- 2-4 years of experience in the biotherapeutic and/or pharmaceutical industry.
- Strong understanding of cGMP, FDA, EMA, ICH guidelines, and ISPE Baseline Guides.
- Proficiency in technical writing for validation and quality documents.
- Strong communication and interpersonal skills for cross-functional collaboration.
Preferences
- Familiarity with ISPE guidelines, including GAMP 5, ASTM E2500, and validation lifecycle principles.
- Understanding of risk-based approaches to commissioning and qualification/validation.
If you are detail-oriented, have a strong commitment to operating ethically, and are ready to make a significant impact in a dynamic environment, we want to hear from you!
Apply today to be a part of our innovative team in Wilson, NC!
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