job summary: 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, Massachusetts job 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 neededInitiate and investigate deviations, and events in a Quality system, e.g. TrackwiseInitiate and author investigations related Out of Specification (OOS) or Out of Trend (OOT) results, deviations, as well as implementing corrective & preventive actionsPerform test results data entry, compilation, and archivingManage inventory and placing orders for materials qualifications: Required Bachelor's degree in microbiology, or related field4+ years of experience in Quality Control, Microbiology or cGMP rolesDisplayed history of increasing responsibility in biotech or related industryKnowledge in Aseptic techniques, cleanroom behavior and Good Manufacturing Practice requirementsGeneral Microbiology knowledge and techniquesWorking knowledge of cell or gene therapy product testing, manufacturing, or development Preferred Master's degree in microbiology or a related fieldExperience in writing deviations or investigations in a quality system (Example: Trackwise)Experience with environmental monitoring testing and product testing (Examples: sterility, mycoplasma, endotoxinExperience in writing & reviewing specifications, protocols, SOPs and Quarterly/AnnualEM trend reportsExperience in Aseptic techniques, cleanroom behavior and Good Manufacturing Practice requirementsExperience in cleanroom gowningExperience 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.