Kelly® Science & Clinical is seeking a Quality and Compliance Specialist for a contract-to-hire opportunity with one of our clients, a biopharmaceutical company focused on metabolic diseases in Vacaville, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries.
Workplace: Vacaville, CA.
Position Title: Quality and Compliance Specialist
Position Type: Direct hire
Pay rate: $30-35/hour
The Quality and Compliance Specialist I is responsible for supporting the implementation and maintenance of the organization’s quality management system. Working collaboratively with cross-functional teams, this role focuses on developing and enforcing procedures, processes, and policies related to quality control, testing, inspection, and audits. The specialist ensures that products and operations comply with both internal standards and regulatory requirements.
Responsibilities:

• Develop expertise in risk assessment and root cause analysis processes for investigations.
  

• Conduct internal audits to ensure compliance with site procedures and applicable regulations.
  

• Evaluate supplier processes and adherence to contractual and regulatory expectations.
  

• Prepare sites for audits and inspections.
  

• Assist in site audits conducted by regulatory bodies and third-party organizations.
  

• Provide quality assurance and compliance support in resolving site issues and concerns.
  

• Review and analyze environmental, personnel, and utility monitoring data and trends.
  

• Maintain up-to-date knowledge of cGMP and other relevant regulatory standards.
  

• Assist or lead training sessions in areas such as risk management, investigations, supplier management, change control, and auditing.

Skills:

• Exceptional written and verbal communication abilities.
  

• Strong analytical, organizational, and record-keeping skills.
  

• Effective project management capabilities, with a focus on timely and budget-conscious completion.
  

• Ability to work independently and as part of a team.
  

• Proven leadership skills with experience overseeing projects.
  

• Proficiency with computers, particularly Windows, Microsoft Word, and Excel.
  

• Ability to follow instructions and perform tasks with varying degrees of supervision.

Qualifications:

• A bachelor’s degree in science or a related field (with a focus on quality assurance, quality control, or engineering).
  

• 2-3 years of related work experience.
  

• Experience with cGMP environments and quality systems.
  

• Facilitation experience in risk management.
  

• Formal training in risk management is strongly preferred.

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