Full-time position
Woodland Hills, CA (On-site)

About EntroGen

Position Overview:

We are seeking a motivated and detail-oriented Quality Control Supervisor to oversee daily operations in the Quality Control department focused on ensuring the integrity and quality of products throughout the manufacturing process.

The QC Supervisor will be responsible for reviewing and compiling comprehensive data reports for batch release, ensuring that the final product meets all specifications before release to the market. Key responsibilities include developing, writing, and revising Standard Operating Procedures (SOPs), Corrective and Preventive Actions (CAPA), and Non-Conformance Reports (NCRs). The QC Supervisor will play a critical role in identifying, documenting, and resolving quality-related issues while ensuring compliance with company and industry quality standards.

This position will require strong cross-functional collaboration, particularly with the Production Department, to ensure smooth coordination between teams, troubleshooting production issues, and optimizing quality outcomes.

The QC supervisor reports directly to the Associate Director of Manufacturing.

Key Responsibilites:

• Quality Control Operations:
  • Oversee the QC team to ensure product integrity and compliance with quality standards.
  • Lead initiatives to maintain high-quality levels across all products, ensuring that they meet both internal and external regulatory standards.
• SOP, CAPA, and NCR Documentation:
  • Write, revise, and enforce Standard Operating Procedures (SOPs) to ensure QC practices align with regulatory requirements.
  • Participate in CAPA investigations and implement corrective actions related to QC and production activities.
  • Manage Non-Conformance Reports (NCRs), ensuring timely investigation and resolution of quality issues.
• Leadership and Team Development:
  • Supervise and schedule QC personnel to ensure timely completion of testing activities.
  • Provide leadership, guidance, and training to the QC team, fostering a culture of continuous improvement and collaboration.
  • Ensure the QC team follows cGMP guidelines and maintains high standards of operation and documentation.
  • Provide performance feedback and participate in hiring and training of QC personnel.
• Cross-functional Collaboration:
  • Work closely with the Production Department to resolve quality issues, ensure production processes meet quality specifications, and facilitate problem-solving.
  • Serve as the QC subject matter expert for the production, research & development, and technical support departments.
• Batch Release and Data Compilation:
  • Review and compile comprehensive data reports for the batch release of final products.
  • Analyze and ensure that all data is complete, accurate, and compliant with regulatory requirements before the final product is released to the market.
• Regulatory Compliance:
  • Ensure compliance with cGMP standards and other applicable regulations in all QC activities.
  • Stay current with industry trends, guidelines, and best practices, implementing changes as necessary to maintain compliance.
• Other related duties as assigned.

Required Qualifications:

• Master’s degree in Biology or Life Sciences with 3-5 years industry experience, OR
• Bachelor’s degree in Biology or Life Sciences with 6-8 years industry experience.
• At least 1-2 years of experience supervising or mentoring laboratory personnel.
• Hands-on experience performing and analyzing qPCR assays.
• Experience authoring/revising SOPs and participating in analytical method validation or verification studies.
• Experience reviewing or implementing in-process and final product specifications and acceptance criteria.
• Competency in Microsoft Excel and data entry.
• Excellent verbal and written skills.
• Strong organizational skills with excellent attention to detail.
• Effective communication skills and the ability to work in a team-oriented environment.
• Ability to lift up to 50 lbs, and perform physical tasks such as standing, bending, and twisting for extended periods.
• Must be authorized to work in the U.S for any employer.

This role operates in a cGMP-controlled manufacturing environment, which includes adhering to strict regulatory standards, and working under stringent deadlines. The position requires regular interaction with production and regulatory teams, and candidates must be comfortable managing multiple tasks and solving problems in a fast-paced environment.

Preferred Qualifications:

• Experience working with molecular diagnostic assays (PCR/NGS).
• Experience with molecular diagnostic instrumentation (qPCR platforms, nucleic acid extraction systems, spectrophotometry, etc.).
• Experience working in an FDA-regulated or ISO 13485 environment.
• Experience participating in internal and external audits.
• Experience executing validation or qualification protocols.

Salary Expectations:

$80,000 – $95,000

Actual salary range for this position will vary depending on qualifications, experience, and relevant skills. Candidates must be local. No relocation assistance is provided. EntroGen also offers a benefit package that includes flexible time off, eligibility for health and dental reimbursement for the employee, and a wellness program.

To apply for this position, please fill out the form below.