The Quality Assurance Associate II (Contractor) is responsible for contributing to the oversight of key strategic, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. Activities include but are not limited to a review of GMP raw data for compliance. The QA Associate II will perform all duties in a manner consistent with site and corporate policies, cGMP, safety, environmental, and human resources policies and procedures and adhere to all regulatory licenses and regulations, interfacing with key Quality and manufacturing customers.
location: Durham, North Carolina
job type: Contract
salary: $23 - 28 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Review and approval of batch related documentation (Solution Lot records, Reports, Logbooks and Release of Autoclaved Equipment) to support product disposition.
- Transport batch related documentation across RTP buildings to support chain of custody and life cycle management.
- Supports 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, and ensure the safety, efficacy and purity of the products manufactured by the company.
- Complete and maintain related GMP training.
- Additional job duties that may be assigned from time to time.
qualifications:
REQUIRED
- 0-2 years directly related to position responsibilities or biologic experience preferred.
skills: Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
