Quality Assurance (QA) Associate

Job Description

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.

QUALIFICATIONS

Education & Experience

• 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.

Knowledge & Skills

• 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.

Physical Requirements

• General Office environment