Quality Manager - Randstad
Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world.
location: Cambridge, Massachusettsjob type: Contract
salary: $55 - 62 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Author and review of GxP documents (e.g.- SOPs, Protocols, Technical Reports, Trend reports etc. related to QC microbiological and Environmental Monitoring activities)
- Support site qualification/validation/commissioning activities as needed
- Initiate and investigate deviations, and events in a Quality system, e.g. Trackwise
- Initiate and author investigations related Out of Specification (OOS) or Out of Trend (OOT) results, deviations, as well as implementing corrective & preventive actions
- Perform test results data entry, compilation, and archiving
- Manage inventory and placing orders for materials
- Bachelor's degree in microbiology, or related field
- 4+ years of experience in Quality Control, Microbiology or cGMP roles
- Displayed history of increasing responsibility in biotech or related industry
- Knowledge in Aseptic techniques, cleanroom behavior and Good Manufacturing Practice requirements
- General Microbiology knowledge and techniques
- Working knowledge of cell or gene therapy product testing, manufacturing, or development
- Master's degree in microbiology or a related field
- Experience in writing deviations or investigations in a quality system (Example: Trackwise)
- Experience with environmental monitoring testing and product testing (Examples: sterility, mycoplasma, endotoxin
- Experience in writing & reviewing specifications, protocols, SOPs and Quarterly/AnnualEM trend reports
- Experience in Aseptic techniques, cleanroom behavior and Good Manufacturing Practice requirements
- Experience in cleanroom gowning
- Experience with MODA® laboratory system
skills: SOP, Quality Assurance, GMP (Good Manufacturing Practice), Manufacturing Operations
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.
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.