Quality Assurance Specialist

Randstad USA Logo
Randstad USA
Thousand Oaks, CA, United States
42.00 - 48.57 USD / Hour
  • Software
  • Applications have closed

Job Summary

  • This position supports Company’s Quality Assurance program under the ATO Plant Quality Assurance organization providing oversight of Commissioning, Qualification, and Validation (CQV) processes in Cell Banking, Drug Substance, Drug Product Filling, Drug Product Packaging/Labeling, General Utility, and Quality Control GMP areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of CQV related processes, procedures, and use of quality systems.

location: Newbury Park, California

job type: Contract

salary: $42.00 – 48.57 per hour

work hours: 9 to 5

education: Bachelors

Responsibilities

  • Primarily responsible for ensuring adherence to equipment and computer validation standards and procedures.
  • Responsibilities include participation in CQV design, review of test protocols, analysis of CQV results, and oversight of summary reports.
  • Provides guidance and sets standards in producing quality documentation and serves as an advisor to Engineering, IS and Manufacturing functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT compliance issues.
  • Executes quality oversight directly in Company Quality systems.

Qualifications

  • Bachelors degree in engineering, Biochemistry, Biology, Chemistry, or related science field.
  • Demonstrated ability to perform or provide oversight of GMP operations including following detailed SOPS, maintaining training, maintaining data integrity principles, and good documentation practices.
  • Experience managing projects through completion while meeting timelines.
  • Evaluating documentation and operations according to company procedures and related regulations.
  • Experience working with Quality Systems.
  • Strong organizational skills and ability to manage multiple tasks at one time.
  • Effective communication skills (both written and verbal).
  • Demonstrated ability to work as both a team player and independently.
  • Solid understanding and application of aseptic behaviors and principles

skills: Biology, Chemistry, SOP Development, Good Manufacturing Practices (GMP), Quality Assurance (QA)

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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (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 with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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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