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Senior Quality Assurance Associate

2 months ago

VilleSavoye, Hauts-de-France, United States Randstad Full time
Job Summary:

We are seeking a highly skilled Senior Quality Assurance Associate to join our team at Randstad. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our manufacturing operations.

Key Responsibilities:
  • Quality Oversight: Provide quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current applicable regulations.
  • cGMP Compliance: Ensure that facilities, equipment, materials, organization, processes, procedures, and products follow cGMP practices and other applicable regulations.
  • Document Review: Perform review and approval of cGMP processes, procedures, documents, and records. Review logbooks, batch records, attachments, work orders, and other GMP documentation.
  • Deviation Management: Ensure that deviations from established procedures are documented per procedures.
  • Record Keeping: Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
  • Risk Management: Alert management of quality, compliance, supply, and safety risks.
  • Training and Development: Complete required assigned training to permit execution of required tasks.
  • Clean Room Operations: Responsible for being in clean room space for the majority of time on shift, which includes gowning in and out of frocks and coveralls.
  • Collaboration: Communicate and collaborate with the PQA shift to ensure required tasks are completed.
Requirements:
  • Education: Bachelor's Degree
  • Experience: 4 years of Quality/Manufacturing experience
  • cGMP Experience: Required
  • Communication Skills: Excellent written and verbal communication skills
  • Decision Making: Experience with decision making
What We Offer:

As a Senior Quality Assurance Associate at Randstad, you will have the opportunity to work with a prestigious life sciences and biopharma company, utilizing your skills and experience to make a difference in the industry. We offer a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).