job summary: Under moderate supervision, the Stability Analyst will be part of the Quality team and responsible for performing stability testing of IVD and ASR products according to SOPs and in compliance with local and global QMS and regulatory requirements. Support the day-to-day activities of the Quality department while adhering to applicable regulatory requirements, ISO 13485, local and global QMS. location: Rocklin, California job type: Contract salary: $20 - 25 per hour work hours: 9 to 5 education: Bachelors responsibilities: Essential Duties and Responsibilities: Perform stability testing of IVD and ASR products according to SOPs and in compliance with local and global QMS and regulatory requirements.Record and document testing results accurately and per applicable regulatory and SOP requirements.Data analysis using Microsoft Excel.Maintain extensive knowledge of Standard Operating Procedures and GMP regulations and guidelines.Troubleshoot equipment problems.Recognize atypical and out of specification results, instrument malfunctions, and methodology issues and participate in the investigation process.Maintain cGMP compliance in the laboratory.Other duties as assigned or required Additional Responsibilities: Maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity to laboratory managementMust be willing and able to work on weekends or extended hours as needed qualifications: REQUIRED QUALIFICATIONS B.S. degree in a biological science or equivalent life sciences degreePrior work experience with medical device, drug, and/or biologics companiesKnowledge in ELISAKnowledge in bioburdenKnowledge in IHC testingAbility to work independently and manage multiple analysesGeneral knowledge of FDA QSRs cGMP, and ISO 13485 or other related industry standardsKnowledge of cGMPs related to QC operationsExperience with Microsoft Excel PREFFERRED QUALIFICATIONS Prior work experience with medical device, drug, and/or biologics companiesPrior experience in ELISAPrior experience in bioburdenPrior experience in IHC testingExperience working in ISO 13485 and/or FDA regulated laboratoryExperience in SAP and/or SAP NEXT skills: Quality control, SOP, FDA, MS-EXCEL, 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. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.