Senior Quality Assurance Specialist
1 week ago
About Us: Collins Consulting is a leading consulting firm specializing in quality assurance, regulatory compliance, and process improvement.
Salary: $120,000 - $150,000 per year based on experience and qualifications.
Job Description:
In this challenging role, you will provide interpretation, guidance, and training on qualification and validation requirements in GLP-, GCP- and GMP-regulated areas. Your responsibilities will include reviewing and approving qualification/validation plan documents, test strategies, test documents, summaries, and certification packages. You will also compile, review, and approve quality documents, including policies, processes, procedures, templates, and formats. Additionally, you will support CAPA activities related to validation and qualification, and provide guidance, direction, and support to peers.
Required Skills and Qualifications:
- Bachelor's degree in Chemistry, Biology, Engineering, Pharmacy, or Microbiology.
- 4-7 years of experience in Quality Assurance or a related field.
- Sound knowledge of current regulatory requirements (21 CFR Part 11, EU GMP Annex 11/15, ICH, PIC/S) and Best Practices (GAMP5).
- Excellent communication and teamwork skills.
- Proven ability to work in a global environment and on virtual teams.
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