Demo

Quality Assurance Analyst (Non-Technical)

Biote
Birmingham, AL Full Time
POSTED ON 2/9/2025
AVAILABLE BEFORE 5/9/2025

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!

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