Quality Assurance (QA) Associate Job at Strides, East Brunswick, NJ

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  • Strides
  • East Brunswick, NJ

Job Description

Job Description

Primary responsibilities of this role include the following:

  • 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.
  • Support with quality matters for disposition of product returns.
  • Assist during FDA inspections and local regulatory inspections at Strides’ US corporate office.

Job-Specific 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.

Qualifications

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

Job Tags

Contract work, Local area,

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