stability analyst.

　　rocklin , california

　　posted 2 days ago

　　job details

　　summary

　　$22 - $25 per hour

　　contract

　　bachelor degree

　　category life, physical, and social science occupations

　　reference47280

　　job details

　　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 supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

　　location: Rocklin, California

　　job type: Contract

　　salary: $22 - 25 per hour

　　work hours: 9 to 5

　　education: Bachelors

　　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

　　qualifications:

　　B.S. degree in a biological science or equivalent life sciences degree preferred, or equivalent combination of education and experience

　　Experience in medical device, drug, and/or biologics

　　General knowledge of FDA QSRs cGMP, and ISO 13485 or other related industry standard

　　Knowledge & experience in ELISA, bioburden and IHC testing

　　Ability to work independently and manage multiple analyses

　　Knowledge of cGMPs related to QC operations

　　Experience working in ISO 13485 and/or FDA regulated laboratory

　　Experience in SAP and/or SAP NEXT

　　Good computer skills, PC including MS Excel

　　Excellent written and verbal skills

　　skills: Quality control, SOP, FDA, MS-EXCEL, GLP (Good Laboratory Practice), 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 [email protected].

　　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).

　　Applications accepted on ongoing basis until filled.

　　Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

　　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.