Quality Assurance Specialist - GMP Batch Release

Cosette Pharmaceuticals Inc.; Lincolnton (NC); Hybrid; USD 55,000 - 85,000; Full time

Job summary

Cosette Pharmaceuticals, Inc. is a US-based pharmaceutical company providing QA support to Manufacturing & Packaging to ensure finished product compliance with SOPs and GMPs.

The role requires performing checks on batch documentation, releasing products, and quarantining non-compliant material. The candidate should have an Associate degree in analytics or 2+ years of related experience, solid problem solving, documentation, and communication skills, and familiarity with Microsoft applications.

Qualifications

• Associate degree in analytical field or 2+ years related experience.
• Pharmaceutical experience preferred.
• Strong problem solving, organization, and communication skills.
• Proficient with PCs and Microsoft Office applications.

Responsibilities

• Perform 1st and 2nd check on batch documentation per SOPs and GMPs.
• Perform record corrections verification and product release.
• Identify and quarantine non-compliant material.
• Coordinate with Production Support Team and internal/external customers.
• Collaborate with other departments to resolve quality issues and investigate non-compliances.
• Support Packaging and Manufacturing issues; communicate issues to team and supervision.
• Perform QA line support activities including verification and release procedures, end of run reviews, QA checks.
• Approve ProCal reports for metrology.
• Use tracking tools and perform inventory control functions; administer the Deviation system.
• Adhere to internal quality systems and procedures and resolve quality issues.

Skills

Leadership

Interpersonal skills

Team building

Problem solving

Documentation

PC proficiency

Microsoft Office

Education

Associate degree in analytical field

2+ years related experience acceptable

Tools

Microsoft Office

Inventory Control

Veeva

Job description

Cosette Pharmaceuticals, Inc. is a US-based pharmaceutical company providing QA support to Manufacturing & Packaging to ensure finished product compliance with SOPs and GMPs.

The role requires performing checks on batch documentation, releasing products, and quarantining non-compliant material. The candidate should have an Associate degree in analytics or 2+ years of related experience, solid problem solving, documentation, and communication skills, and familiarity with Microsoft applications.