Job Description

Biote Medical is the world leader in hormone optimization and we are adding to our team! We partner with providers to take a complete approach to healthier aging through patient-specific bioidentical hormone replacement therapy and the only nutraceutical line created specifically to support hormone health.

We're looking for a QA Analyst to join Asteria Health (a Biote Company), located in Birmingham. This position is responsible for performing Quality Assurance activities with a focus on complaint, nonconformance, and deviation handling. The critical skills for this role are demonstrable technical writing abilities and a drive towards continuous improvement.

This is a Non-Technical QA role. We need someone from the pharma/healthcare side of QA.

You must be located in the Birmingham area to be considered, as well.

The QA Analyst for Asteria Health:

• 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.)
• Familiar with regulatory guidance and proposed changes as they apply to 503b manufacturing facilities.
• 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.
• Conducts CAPA effectiveness checks and documents results.
• Executes change controls and develops training to support corrective actions as required.
• Attends all required meetings and provides clear, professional verbal and email communication.
• Performs other duties as assigned.

As the QA Analyst, your background should include:

• Bachelor’s degree in scientific discipline/engineering (required).
• At least three years of practical experience in a Quality role in an FDA regulated company. (required)
• Experience working on cGMP guidelines and demonstrated expertise in a variety of the field’s concepts, practices, and procedures. (required)
• Preferred: Continuing education such as ASQ or Six Sigma certification.
• Experience working with Production or Manufacturing.
• Must exhibit excellent verbal and written communication skills.
• Must exhibit excellent attention to detail.
• Exceptional computer skills (data entry, Microsoft Office products, Adobe, inventory management software, eQMS).
• 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.

Additional Notes

• Must be willing and able to gown for ISO 8 area.

If you're interested learning more about this awesome opportunity, please apply today!

Job Tags

Similar Jobs