QA Associate

ANI Pharmaceuticals • Hightstown, NJ

1d • Hybrid

About The Position

This position is responsible for providing support to the Manufacturing and Packaging operations to ensure relevant procedures are followed and meet cGMP requirements.

Requirements

• Bachelor’s degree
• 5 years’ experience in Quality Assurance
• Computer skills
• Previous work in a regulated environment
• Problem solving skills
• Ability to coordinate multiple tasks in a fast-paced environment
• Ability to read and follow procedures
• Ability to work independently
• Attention to detail
• Excellent interpersonal skills
• Excellent organizational and follow-through skills
• Excellent written and verbal communication skills
• Knowledge of cGMPs
• Must be able to work within a team environment
• Strong organizational skills

Responsibilities

• Perform packaging line inspection/audits and provide assurance that packaging operations are compliant with applicable SOPs and cGMPs.
• Perform finished product attribute sample inspection and evaluation of finished products’ physical characteristics prior to packaging.
• Perform annual retain sample inspections and control finished product and raw material retain samples stored in the reserve sample room.
• Monitor GMP areas for compliance with general GMP requirements such as proper gowning and cleanliness, per CFR21 Subpart A General Provisions to assure they reflect current practices and meet industry standards and cGMP requirements.
• Assist with maintenance of Supplier Quality program, to potentially include performing external audits.
• Assist as required in the stability department, with validation activities, and/or annual report assembly.
• Perform other duties as assigned or requested.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level