Stability Analyst

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 management
• Must 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 degree
• Any prior work experience with medical device, drug, and/or biologics companies
• Knowledge in ELISA
• Knowledge in bioburden
• Knowledge in IHC testing
• Ability to work independently and manage multiple analyses
• General knowledge of FDA QSRs cGMP, and ISO 13485 or other related industry standards
• Knowledge of cGMPs related to QC operations
• Experience with Microsoft Excel
  
  

Prefferred Qualifications

• 1 years iof work experience with medical device, drug, and/or biologics companies
• Prior experience in ELISA
• Prior experience in bioburden
• Prior experience in IHC testing
• Experience working in ISO 13485 and/or FDA regulated laboratory
• Experience 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.

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