Quality Assurance (QA) Associate

Strides Pharma Inc • Bridgewater, NJ

6d • $55,000 - $65,000 • Onsite

About The Position

This role is for a Quality Assurance (QA) Associate. The primary responsibilities involve supporting various quality assurance functions for products manufactured outside the US and for Strides Pharma Inc. (Strides) frontend products. This includes batch release authorization, drug product complaint management, recall management, review of quality agreements, coordination with contract testing laboratories, and deviation review.

Requirements

• Excellent verbal and written communication skills are necessary.
• With supervision and direction, effectively prioritizes competing tasks in a fast-paced and dynamic environment
• Motivated, results driven with attention to detail, accuracy and clarity.

Nice To Haves

• Bachelor’s degree in Pharmacy, Chemistry, Biology or Microbiology is preferred
• 1 to 2 years of Quality Assurance or related pharmaceutical industry experience is preferred. Recent graduates will be considered for this role.

Responsibilities

• With Supervision, review documents/records and provide batch release authorization to 3PL service provider for products manufactured outside of the US
• Support Drug Product Complaint management; forwarding to respective drug product manufacturing site and coordinate with corporate QA for investigations.
• Support Drug Product recall/field alert management.
• Assist with review of Quality Agreements
• For applicable products, coordinate with Contract Testing Laboratories for Analytical Method Transfer activities, Drug Product testing, any OOS results, and test method issues.
• With supervision, review deviations/investigations related to Strides Pharma Inc (Strides) frontend products.
• Assist with SOP management for Strides’ US corporate office.

What This Job Offers

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