Quality Assurance Associate - Production Support

About the Company

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. The company has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions, and suppositories, leading to consistent supply to customers and commercialization success. Cosette operates corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas.

About the Role

Provide QA support to Manufacturing & Packaging. Ensure finished product complies with all regulatory requirements through review of batch documentation in accordance with appropriate SOPs and GMPs. Ability to perform listed tasks independently.

Responsibilities

• Perform 1st and 2nd check on completed batch documentation per applicable SOPs and GMPs.
• Perform record correction verification and product release.
• Identify and quarantine non-compliant material.
• Interact positively within the Production Support Team and with internal/external customers.
• Coordinate with other departments to complete QA tasks successfully; assist with resolution of issues and provide feedback on investigation of non-compliant situations.
• Support Packaging and Manufacturing issues.
• Utilize knowledge of SOPs and GMPs to resolve quality issues and communicate details to team members and supervision.
• Perform QA Line Support activities including verification and release procedures, end-of-run reviews, and QA checks.
• Approve ProCal reports for metrology.
• Use departmental tracking tools (e.g., databases).
• Perform necessary Inventory Control functions (release, quarantine, etc.).
• Administer the Deviation system.
• Adhere to and enforce internal quality systems and procedures.
• Other duties as assigned.

Requirements

• Associate’s Degree in an analytical field of study or two (2) plus years of applicable experience. Relevant work experience may substitute for the education requirement.
• Relevant experience in a pharmaceutical environment.
• Leadership qualities, interpersonal and team-building skills.
• Good problem-solving, organization, documentation, and communication skills.
• Good working knowledge of PCs and Microsoft applications.

Skills

• Microsoft Applications
• Inventory Control
• Veeva

Physical Requirements

• Ability to occasionally lift 50 pounds.
• Ability to sit at a workstation for extended periods of time.