Role OverviewAs a Quality Assurance Specialist, you will be responsible for documenting and auditing cGMP practices for the site, developing and revising QA procedures to strengthen cGMP compliance.
What You Will Do
Key responsibilities include acting as a departmental resource for cGMP manufacturing programs, working collaboratively with all departments to ensure manufacturing programs are delivered on time, and making and acting upon GMP decisions.
Why It Might Be a Fit
The ideal candidate will have a strong knowledge of cGMP guidelines, excellent written and oral communication skills, and experience in writing and reviewing GMP documents.
Requirements
- BS/BA in science with 1-3 years Quality Assurance cGMP experience
- Associate degree with 5+ years of Quality Assurance cGMP experience in API manufacturing or related industrial experience
- High level of knowledge in cGMP guidelines as specified in ICH Q7A
- Experience in writing and reviewing GMP documents
- Ability to solve complex, non-routine analytical problems
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