Job Title: QA Associate

Work Location: Plymouth County, Massachusetts

Summary:

The Quality Assurance Associate will contribute to the daily operations of the Quality Assurance Department, supporting the manufacturing of liquid, semi-solid, and powder formulations of both prescription and OTC products. The role requires a highly professional team player with strong attention to detail and excellent organizational skills. The QA Associate is responsible for reviewing and releasing all raw material and packaging components receiving and batch records for commercial distribution.

Responsibilities:

• Monitor Batch Record Review/Release
• Compilation of all necessary components of batch records.
• Checking and effecting correction of, completeness, clarity, and conformance of above components of the batch records to cGMP standards.
• Assuring that all testing results are within specifications. Assure all laboratory notebooks and raw data support the results.
• Approving transfer of product to inventory.
• Verify data and generate certificates of analysis from testing data for appropriate products.
• Internal Audits (Team Member)

Qualifications:

• Bachelor’s Degree
• Experience in Quality Assurance preferred.
• Proficient in Microsoft Office – Outlook, Excel, Word
• Excellent verbal and written communication
• Strong Analytical Skills
• Strong attention to detail; must be detail-oriented, demonstrates accuracy and thoroughness.
• Good problem solver
• Ability to multitask – work on multiple projects simultaneously with sense of urgency.
• Strong organizational skills; prioritizes and plans work activities and uses time efficiently.
• Works well in a team environment but can work independently.

Published Category: Quality & Validation