Quality Assurance Coordinator (NIGHTS)
About The Position
The Quality Assurance Coordinator ensures consistent quality across manufacturing processes by issuing, tracking, reviewing, and evaluating documents and records associated with GMP manufacturing and packaging operations. The role reviews materials, test results, and production records against written specifications, enters product dispositions, and supports quality standards through inspections, audits, testing, and documentation review. The coordinator also works with operations to resolve documentation errors, manages non-conforming inventory documentation, and supports electronic archiving in accordance with Pharmavite retention policy. This position promotes a culture of quality through technical skills and knowledge of cGMP.
Requirements
- High school diploma/GED or equivalent work experience.
- At least 1 year of related experience.
- Experience with quality measuring and testing equipment.
- Ability to speak, read, and write English.
- Clear communication and interpersonal skills.
- Computer skills in data entry and processing, including Microsoft Word and Excel.
- Ability to conduct simple mathematical calculations.
- Ability to prioritize workload while meeting deadlines.
- Organizational skills.
- Attention to detail.
Responsibilities
- Review bulk, components, labels, laboratory test records, and finished goods to ensure documents and results meet written specifications, and enter disposition in the system.
- Sample, inspect, and review documentation for bulk, components, labels, and finished goods to ensure quality standards are met.
- Review and approve minor non-conformances and batch production change controls.
- Review work order cover sheets for manufacturing batch records, logbooks, and protocols, ensuring completeness and accuracy before filing.
- Work cross-functionally with operations to resolve documentation errors.
- Conduct in-process audits and testing as assigned to support established procedures.
- Prepare reject notices for non-conforming inventory to ensure the quarantine process is followed.
- Track receipt and/or issuance of technical documents associated with product manufacture.
- Prepare and scan manufacturing batch records, packaging records, and protocols for electronic archiving under Pharmavite retention policy.
- Promote a culture of quality using technical skills and knowledge of cGMP.
Benefits
- Medical, dental, and vision benefits.
- 401(k) match.
- Annual performance bonus may be included.
- Other wellness benefits.
- Career development and learning opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
