Quality Systems Specialist

Job DescriptionJob Descriptionjob Summary

The Specialist Manufacturing will support the External Supply organization by owning and executing quality records under limited supervision. This includes Deviations (minor and major), Corrective and Preventive Actions (CAPAs), Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR/EN), and Change Control records. The role involves cross-functional collaboration with internal stakeholders and external suppliers to ensure timely closure of records and compliance with internal procedures and regulatory requirements.

location: Newbury Park, California

job type: Contract

salary: $42.00 - 47.11 per hour

work hours: 9 to 5

education: Bachelors

Responsibilities

• Own and manage supplier-related quality records (e.g., deviations, change controls) originating from external manufacturing sites, ensuring timely progression and closure.
• Review, address and close quality records (Deviations, Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR / EN), and Change Controls in accordance with internal quality management systems and in compliance with applicable regulatory requirements
• Monitor and investigate deviations under External Supply ownership; lead root cause analysis and implement appropriate CAPAs. Collaborate cross-functionally to drive a mature and effective Deviations and CAPA process.
• Develop and present quality record summaries for Senior Management reviews. Deliver timely, accurate updates on process status, risks, and key milestones to senior leadership.
  
  

Qualifications

• Bachelor's degree in a scientific or engineering discipline
• Three (3) - five (5) years of experience in a GMP regulated biotech or pharmaceutical environment
• Hands-on experience managing quality records as a record owner, including Deviations, CAPAs, Change Controls, and Supplier Investigation
• Proficiency with quality systems software such as TrackWise or Veeva
• Experience leading root cause investigations and working directly with suppliers
• Strong documentation and communication skills with an ability to lead cross-functional meetings and drive consensus
  
  

skills: FDA, Quality Assurance, CAPA, ICH Regulations

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: 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 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.