About the Company:
Lead Quality Assurance
Provides Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.
Responsibilities:
- Perform QA review and approval on SOPs, forms, WI, and other document types.
- Reviews and approves Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities.
- Reviews and Approves Analytical related documents such as Test Methods, Test Method, Transfer Plans and Assessments.
- Provides Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.
Qualifications:
Minimum Education: HS or AA degree, with 5+ years of experience Bachelors and or 8+ years of experience Minimum of 5 years of experience must be in quality, more experience welcomed.
Required Skills:
- Industry Knowledge, only support QC lab documentation, testing - will not support manufacturing.
- MS Office.
Preferred Skills:
- Veeva experience a plus!
- Experience as QA Lead on projects.
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit
The Company will consider qualified applicants with arrest and conviction records.