QC Lab Support Specialist

Job Description

The QC Lab Support Specialist supports quality and compliance processes across the QC Lab organization. This role handles tasks such as coordinating with external laboratories, overseeing inventory, managing preventive maintenance and calibration schedules for QC lab instruments, collaborating with vendors for advanced technical support, and compiling essential metrics and quality data reports. The Specialist conducts lab investigations, assists in resolving deviations, and supports the implementation of Corrective and Preventive Actions (CAPAs) to mitigate risks and enhance practices.

Acting as a QC lab gatekeeper, this role evaluates compliance gaps, leads SOP revisions and reviews, and drives process improvements, fostering a culture of continuous improvement and quality excellence in QC operations.

salary: $35 - $40 per hour
shift:
First
work hours: 8 AM - 5 PM
education:
Bachelors

• Support daily operations by coordinating activities, troubleshooting, and coordination to enhance department metrics.
• Promptly address and resolve issues in Lab Support team-managed processes.
• Facilitate external lab testing processes to support product release timelines.
• Organize preventive maintenance for QC lab instruments and coordinate with vendors.
• Manage equipment and reagent/inventory controls.
• Serve as the primary point of contact for QC CAPAs, gap assessments, and overseeing reviews of SOPs.
• Write and review SOPs and documents to ensure compliance with regulatory policies.
• Assist in preparing and maintaining annual quality reports (Product Quality Review (PQR), Yearly Biologic Product Report (YBPR)) and reviews.
• Participate in the investigation of sample discrepancies and product deviations.
• Conduct laboratory investigations to ensure issues are resolved efficiently.
• Support and mentor teams in problem-solving sessions to implement corrective actions.
• Collaborate in lab investigation and deviation-related meetings to support QC team members and uphold compliance standards.
• Support audits by maintaining records and preparing reports for closing observations.
• Assist in representing the department during product releases and compliance audits.
• Contribute to Lean or Six Sigma projects, applying tools like DMAIC and 5S to enhance processes.
• Ensure data integrity and compliance with company and regulatory standards.

• working in a smoke free environment
• wearing steel toe shoes

• Quality Control
• CAPA
• Chemisty
• GMP
• GDP
• Compliance
• Laboratory/Sciences

• Years of experience: 1 year
• Experience level:
  Experienced

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

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 consis