What are the responsibilities and job description for the Senior Specialist Quality Assurance - III position at Careers Integrated Resources Inc?
Job Title: Senior Specialist Quality Assurance - III
Job Location: Durham, NC
Job Duration: 12 Months (possibility of extension)
Job Location: Durham, NC
Job Duration: 12 Months (possibility of extension)
Responsibilities:
- Batch record review/approval.
- Technical protocol review/approval.
- Equipment qualification protocol review/approval.
- Deviation review/approval.
- Execute shop floor quality audits.
Education and Experience:
- Quality Assurance professional with at a minimum a BS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years experience in the Pharmaceutical Industry.
- Would consider Associates w/good relevant experience.
- Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products.
Skills and Competencies:
- Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills.
- Must have very strong relationship building skills.
- Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing, sterile process validation and/or sterile process technology transfer.
