Quality Assurance Engineer
$75,000–$85,000 year
On-site · Miramar, Florida, United States
Job Summary
The Quality Assurance Engineer serves as the subject matter expert for Compliance related to Production Operations, assisting in Incident/Deviation investigations and updating production-related documentation. Responsibilities include reviewing and approving investigations and validation documents, leading investigation teams, recommending improvements in manufacturing controls, and ensuring compliance with GMPs and safety regulations. The role demands strong analytical, troubleshooting, and organizational skills with a focus on cross-departmental collaboration. A Bachelor’s degree in Engineering or Life Sciences with relevant experience is required, along with knowledge of various regulatory requirements and documentation practices.
Required Qualifications
- A Bachelor's degree in Engineering or Life Sciences with a minimum of 5 - 8 years experience in cGMP regulated manufacturing environment or a Master’s degree and 3-5 years of experience.
- Knowledge of GMP’s (21 CFR Parts 210 and 211).
- Sound knowledge of the FDA, Health Canada, and other pharmaceutical regulations.
- Strong organizational skills.
Desired Qualifications
- Knowledgeable in multiple instrumentation techniques such as HPLC, GC, UV-VIS, dissolution equipment, pH measurement, titration, etc.
- Knowledgeable in analytical testing of API, excipients and components following compendial and validated methods.
- Analytical chemistry and common instrumentation
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