Manufacturing Quality Specialist

1 week ago


north billerica, United States Randstad Life Sciences US Full time

Job Overview

We are seeking a highly skilled Quality Engineer to join our team at Randstad Life Sciences US.

About the Role

This is a 6 month contract / temp to perm position, working 100% onsite from Monday - Friday, 3rd shift in North Billerica, MA.

Salary

The salary for this role is estimated to be between $50-55 per hour.

Job Description

As a Quality Engineer, you will provide quality oversight activities for the aseptic fill/finish manufacturing suite and quality assurance technical expertise to ensure compliance with company guidelines and CGMP regulations.

Key Responsibilities

  • Conduct investigations and make recommendations for targeted data and information collection as required for quality events.
  • Collaborate with cross-functional production support teams to identify root cause and determine appropriate corrective action/preventative actions for investigations.
  • Resolve unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on evidence.
  • Review and approve protocols, validation documents, investigations and procedures.
  • Approve change controls and represent Quality in Change Control Board meetings as needed.
  • Provide Quality on the floor presence in support of manufacturing operations.
  • Represent QA in a range of internal team meetings, processes and initiatives.
  • Alert management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions.
  • Actively promote safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
  • Actively demonstrates the company values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.

Requirements

  • Bachelor's degree in a scientific discipline with 2 years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent.
  • Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies and facilities is preferred.
  • Ability to travel up to 10% domestically.


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