USA-Quality Assurance Lead III (Scientific) - First Shift - Randstad USA

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!

 
location: Waltham, Massachusetts
job type: Contract
salary: $81.00 - 84.30 per hour
work hours: 8 to 4
education: Associate
 
responsibilities:

- Provides Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.

- Perform QA review and approval on SOPs, forms, WI, and other document types

- Reviews and approves Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities

 
qualifications:

- Education: HS or AA degree, with 5+ years of experience; Bachelors and or 8+ years of experience

- Minimum of 5 years of experience must be in quality, more experience welcomed

- Reviews and Approves Analytical related documents such as Test Methods, Test Method, Transfer Plans and Assessments.

**Must Have:

- Industry Knowledge, only support QC lab documentation, testing - will not support manufacturing

- Reviews and Approves Analytical related documents such as Test Methods, Test Method, Transfer Plans and Assessments.

- Provides Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.

- MS Office

**Nice to Have:

- Veeva experience a plus!

- Experience as QA Lead on projects

 
skills: Quality control, SOP

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.