Quality control review resource
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. We are currently partnering with a company known for their leading clinical trials as well as Research & Development. With the goal to constantly develop innovative products, you will feel secure in the fact that you are making a difference. Apply for your dream job now!
location: Westborough, Massachusetts
job type: Contract
salary: $40 - 49 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Conduct quality control (QC) review, including verification of data against approved supporting documentation/sources for aggregate reports.
- Performs data integrity review of CMC data and reports intended for regulatory filings.
- Ensures integrity, accuracy, and consistency of data and documents.
- Record QC metrics per defined categories.
Required
- BA/BS or equivalent with typically 3+ years relevant experience in a biotechnological and/or pharmaceutical Quality Assurance setting.
- Experience in a pharmaceutical development environment with knowledge and review experience on development study protocols and reports for investigational stage products.
- Excellent oral and written communication skills.
- Ability to perform and verify mathematical determinations utilizing both calculator and computer programs, such as MS Excel.
- Ability to work effectively in a matrix setting to resolve issues and achieve common goals
- Previous experience with cell therapy development or cell-based assays (technical or quality review).
- Experience working under GxPs and/or knowledge of GMP, ICH, USP and global compendial regulations and guidance.
skills: CMC, Quality control, SOP, 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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.