Quality Systems Specialist

Randstad USA; Thousand Oaks (CA); Remote; USD 80,000 - 100,000; Full time

Job summary

A leading staffing partner is seeking a Specialist Manufacturing to manage quality records in biotechnology. This role involves ensuring compliance with regulatory requirements and driving quality processes across teams. Ideal candidates will have a Bachelor's degree and experience in quality record ownership, particularly in biotech. The position offers telecommuting options and a contract type.

Benefits

Health Insurance

401K contribution

Incentive and recognition program

Qualifications

• 3-5 years experience in quality record ownership.
• Experience in biotech industry.

Responsibilities

• Ownership of supplier-related quality records.
• Manage deviations and CAPAs under quality management system.
• Build and present quality records summaries for management.

Skills

SOP

Quality Assurance

CAPA

Education

Bachelor's degree

Tools

Veeva

Trackwise

Job description

job summary:
As a trusted staffing and recruitment partner, we are committed to connecting you with the perfect opportunity at a global leader in biotechnology. Leveraging our extensive network, we provide access to top-tier roles that allow you to grow and make a meaningful impact in the healthcare and life sciences industries. This company is dedicated to discovering and developing innovative therapies that address serious diseases, with a focus on oncology, cardiology, and bone health. With a strong legacy of scientific excellence and a mission to improve patient outcomes worldwide, they offer a dynamic environment where your contributions will drive real change. If you're seeking a rewarding career that makes a difference, let us help you take the next step!


location: Telecommute
job type: Contract
salary: $42.00 - 47.11 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Ownership of supplier-related quality records (e.g., deviations, change controls), supplier focused.
• The Specialist Manufacturing is expected to own and execute under minor supervision all the processes related to deviations (minor and majors), Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control quality records. This Specialist Manufacturing will act as the External Supply representative across functional teams and drive closure of quality records in a timely manner. The Specialist Manufacturing, External Supply owns and manages quality records originating from manufacturing sites across the Company network.
• Address and close quality records (Deviations, Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control) under the company's quality management system procedures and ensures compliance with regulatory agency requirements.
• Monitors and investigate deviations owned by External Supply and implements corrective / preventive actions. Partner cross-functionally across the site to ensure maturity and execution of robust Deviations / CAPA process
• Build and present quality records summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management

qualifications:

• Bachelor's degree with 3-5 years experience.
• Quality record owner experience (I.e. Deviations, Supplier investigations, CAPA, and Change Control)
• Basic knowledge of Veeva or Trackwise
• Biotech industry experience

skills: SOP, Quality Assurance, CAPA

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 [e-mail].

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.

• Bachelor's degree with 3-5 years experience.
• Quality record owner experience (I.e. Deviations, Supplier investigations, CAPA, and Change Control)
• Basic knowledge of Veeva or Trackwise
• Biotech industry experience