Quality Assurance Coordinator (NIGHTS)

Pharmavite • New Albany, OH

3d

About The Position

The Quality Assurance Coordinator ensures consistent quality across manufacturing processes by issuing, tracking, reviewing, and evaluating documents and records for GMP manufacturing and packaging operations. The role reviews and dispositions materials and finished goods against written specifications, supports nonconformance and change-control review, and works with operations to address documentation errors. It also supports in-process audits and testing, inventory quarantine, technical-document tracking, and electronic archiving of manufacturing and packaging records in accordance with Pharmavite retention policy. The 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, Microsoft Word, and Microsoft Excel.
• Ability to conduct simple mathematical calculations.
• Ability to prioritize workload while meeting deadlines.
• Organizational skills.
• Attention to detail.

Responsibilities

• Review bulk materials, components, labels, laboratory test records, and finished goods to ensure documentation and results meet written specifications, and enter disposition in the system.
• Sample, inspect, and review documentation for bulk materials, components, labels, and finished goods to ensure quality standards are met.
• Review and approve minor nonconformances and batch production change controls.
• Review work order cover sheets for issuance of 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 according to 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.
• Compensation for overtime hours worked by non-exempt employees in accordance with state and federal law.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED