Quality Assurance Analyst @ Biote

QA & Testing (1)

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.

You must be located in the Birmingham area to be considered.

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)
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. (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!

Quality Assurance Analyst

Quality Assurance

Biote

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