Biote Medical is looking for a QA Analyst to join Asteria Health to focus on complaint, nonconformance, and deviation handling within their hormone optimization and nutraceutical product lines.
Requirements
- At least three years of practical experience in a Quality role in an FDA regulated company.
- Strong technical writing skills is required.
- Experience working on cGMP guidelines and demonstrated expertise in a variety of the field’s concepts, practices, and procedures.
- Exceptional computer skills (data entry, Microsoft Office products, Adobe, inventory management software, eQMS).
- Familiar with regulatory guidance and proposed changes as they apply to 503b manufacturing facilities.
- Conducts CAPA effectiveness checks and documents results.
- Executes change controls and develops training to support corrective actions as required.
Responsibilities
- Logs, trends, and documents Deviations, Non-conformances, and customer complaints.
- Ensures quality events are escalated and effectively communicated across departments.
- Conducts risk assessment and root cause analysis using Quality tools (FMEA, gap analysis, etc.)
- Assists with studies to inspect, test, and evaluate the reliability of manufacturing processes, products, and equipment.
- Performs trending on key metrics and present to Senior Leadership Team.
- Supports the CAPA program.
- Works cross-functionally to complete Corrective and Preventative Actions (CAPAs) in a timely manner.
Other
- You must be located in the Birmingham area to be considered.
- Must exhibit excellent verbal and written communication skills.
- Must exhibit excellent attention to detail.
- Ability to work as part of a small team in a fast-paced environment.
- Possess time management skills and the ability to work independently, multitask, complete projects according to deadlines.
