Job Description

Randstad Enterprises is a partner for talent that creates successful end results!

In this Quality Associate position, you will have an opportunity to work in a well-respected Biotechnology company AND have the support you need with a career coach guiding you towards success :)

** PLEASE DO NOT APPLY if you live outside the Raleigh-Durham area **

Why work a contract position with Randstad?

• Opportunity - Opportunity - Opportunity
• Career Advisor to assist
• Benefits available (Medical/Dental/Eye)
• Strong conversion rate to a full-time employee (avg 2 per month)
• Robust on the job training and eLearning's
• 6-month contracts with possibility of extension dependent on availability and performance·
• 100% onsite at the client's facility in RTP, NC (cafeteria, Starbuck's, gym)
• Mon – Fri, standard work weeks and hours with occasional overtime

Quality Assurance Associate - Large and Small Scale Biomanufacturing -

You will support and contribute to key strategic and operational aspects within the teams with activities including review of GMP raw data for compliance and perform all duties consistent with site and corporate policies, cGMP, safety, environmental, and human resources policies and procedures, adhering to all regulatory licenses and regulations.

• Work within the internal QA group supporting documentation creation, update, reviews, provide meeting support, support design questions making recommendations on improvements, compliance where appropriate.
• Support batch record traceability mapping activities in addition to other assignments as required by group management.
• Collaborate with project teams, contractors, and site operations staff.

Main Responsibilities:

• Review and approval of batch related documentation (Solution Lot records, Reports, Logbooks and Release of Autoclaved Equipment).
• Transport batch related documentation across RTP buildings supporting chain of custody and life cycle management.
• Resolution of both technical and compliance issues/gaps of mild to moderate complexity.
• Assists Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, ensuring the safety, efficacy and purity of the products manufactured.
• Complete and maintain GMP training.
• Opportunity to contribute to projects.

Qualifications | Skills:

• Experienced QA associate within a large molecule, drug substance facility
• 5+ years of experience within the pharmaceutical, biotech industry
• Regulatory requirements in the pharmaceutical industry (FDA, EMA)
• Able to manage multiple tasks in a fast-paced environment
• Experience working within a matrix teams’ environment

Education:

• Bachelor’s degree in science, engineering, or other technical field of study

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