Company:  Confidential

Job Title: QC Supervisor

Job Number: 33770

Location: San Diego, CA

Job Description

We have an immediate opening for a Quality Control (QC) Supervisor responsible for overseeing the stability program, training associates in various assays, conducting QC testing, analyzing data, investigating Out-of-Specification (OOS) cases, monitoring the environment, and validating/qualifying assays. Additionally, the incumbent will work closely with the development team to create new assays and analytical techniques. We are in search of enthusiastic candidates who can work independently within a collaborative setting.


  • Establish and take charge of the stability program for both new and existing products.
  • Generate technical reports and documentation, including reports on deviations, qualification/validation protocols, and investigations into Out-of-Specification (OOS) results.
  • Collaborate with the Research and Product Development Department to diagnose and enhance current assays and forthcoming analytical methods.
  • Conduct QC analysis testing on current products to support batch approval, encompassing testing at various stages, such as in-process intermediates, final formulated bulk drug substance, and the end drug product.
  • Manage relationships with external laboratories to coordinate the receipt of samples, testing procedures, and the timely reporting of results.
  • Collaborate closely with the Manufacturing and Quality Assurance teams to address facility and product-related issues.
  • Cultivate and maintain mammalian cell cultures.
  • Engage in data analysis, as well as the organization of records, reports, and databases, ensuring timely completion.
  • Train other team members in relevant techniques and procedures as necessary.
  • Draft or revise Standard Operating Procedures (SOPs) for quality control.
  • Perform Environmental Monitoring of the manufacturing facility and relevant samples generated.
  • Coordinate with third-party vendors to uphold equipment calibration.
  • Work with minimal supervision to achieve project objectives.
  • Present internal data effectively.
  • Receive and inspect incoming materials.
  • Fulfill any other assigned duties as required.

Required Skills

  • A minimum of 5 years of experience in a GMP Quality Control laboratory or a combination of experience within a GMP/GLP environment is mandatory.
  • Demonstrated supervisory experience of at least 2 years in a GMP setting is essential.
  • Proficiency in mammalian cell culture techniques and molecular biology skills.
  • Expertise in laboratory methods, including flow cytometry, qPCR, RNA/DNA isolation, ELISA, and endotoxin detection.
  • Familiarity with method qualification/validation is preferred.
  • The capability to independently conduct laboratory analyses, troubleshoot issues, and enhance methods.
  • A track record of successful independent work within a laboratory setting.
  • Exceptional communication skills, effective time management, and the ability to collaborate within a team are imperative.
  • Strong project management and organizational abilities.
  • Robust leadership skills to oversee teams and manage QC specialties, stability programs, and sample management.
  • Proficiency in Operational Excellence skills, such as 5S and lean principles, is advantageous.
  • Computer literacy, including proficiency with Outlook, MS Office, and other electronic systems.
  • Capacity to don appropriate attire and work within a classified area, with a bonus for experience in aseptic processing.
  • A Bachelor's degree in a relevant Biological Science discipline is required.

Compensation and Benefits:
Salary range: $95,000 to $115,000/year

Health Insurance (medical, dental, vision)
Life Insurance
Short- and Long-Term Disability
Paid Time Off (PTO)


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