Quality Assurance (QA) Associate

Strides Arcolab Ltd.; East Brunswick Township (NJ); On-site; USD 55,000 - 65,000; Full time

Job summary

A leading company in the pharmaceutical sector is looking for a Quality Assurance (QA) Associate in East Brunswick, NJ. The role offers an excellent opportunity for recent graduates and includes responsibilities such as document review, complaint management, and supporting compliance during inspections. Join a dynamic team focused on maintaining high quality standards in drug production.

Qualifications

• 1-2 years of Quality Assurance or related pharmaceutical industry experience preferred.
• Recent graduates will be considered.

Responsibilities

• Review documents/records and provide batch release authorization to 3PL service providers.
• Support Drug Product Complaint and Recall management.
• Assist during FDA inspections.

Skills

Communication

Attention to Detail

Prioritization

Education

BS degree in Pharmacy, Chemistry, Biology or Microbiology

Job description

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This range is provided by Strides. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$55,000.00/yr - $65,000.00/yr

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.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Hospitals and Health Care, Non-profit Organizations, and Government Administration

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