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Director, Quality Control - 20672

$130,000 - $150,000/Yr

Simply Biotech - San Diego, CA

posted 2 months ago

Full-time - Senior
San Diego, CA

About the position

The Director of Quality Control (QC) at Simply Biotech is responsible for overseeing the quality assurance processes for proteins, assay kits, cell culture media, cell lines, lentiviruses, and detection buffer products. This role is crucial in maintaining product integrity, regulatory compliance, and ensuring high-quality standards in drug discovery and development. The position requires strong leadership and technical skills to manage the QC team and implement effective quality management systems.

Responsibilities

  • Oversee the testing of raw materials, intermediates, and final assay kits to ensure accuracy, sensitivity, specificity, and consistency.
  • Ensure that cell culture media batches meet all required sterility, pH, osmolality, and nutrient composition specifications.
  • Validate cell lines for identity, purity, functionality, viability, and contamination.
  • Ensure the detection buffer's stability, sensitivity, and compatibility with assays, testing for contamination and chemical properties.
  • Review and approve batch records, ensuring compliance with quality standards before market release.
  • Develop and validate QC testing methods for new and existing products, ensuring reliability and compliance with ISO 9001:2015 standards.
  • Validate assay sensitivity, specificity, and robustness for detection buffers and ensure cell culture media supports consistent cell growth.
  • Document all QC data accurately and in compliance with Good Documentation Practices (GDP) and electronic record-keeping regulations.
  • Maintain a robust Quality Management System (QMS) to ensure traceability and compliance with ISO 9001:2015 standards.
  • Lead and mentor the QC team, ensuring staff are trained on relevant SOPs and quality standards.
  • Investigate non-conformances, out-of-specification results, and product failures, implementing corrective and preventive actions (CAPA).
  • Conduct root cause analyses and work with cross-functional teams to mitigate risks and prevent recurrence of quality issues.
  • Ensure all QC activities adhere to relevant regulatory frameworks, including GLP for testing and ISO 9001:2015 standards.
  • Prepare for and manage customer audits and internal quality audits.
  • Drive process improvement initiatives to enhance QC efficiency and accuracy, including automation or advanced technologies.
  • Implement Lean, Six Sigma, or other continuous improvement methodologies to reduce errors and enhance product quality.
  • Coordinate with suppliers to ensure raw materials meet quality specifications.

Requirements

  • Degree in a relevant field such as biotechnology, molecular biology, biochemistry, cell biology, or analytical chemistry.
  • 8+ years of experience in QC within the life science industry, specifically with ISO 9001 and cGMP standards.
  • Proficient with analytical method development and validation.
  • Strong understanding of proteins, assay kits, media, or other cell-based products.
  • Advanced degree (PhD preferred) in a relevant field.
  • Minimum 10 years of experience in quality control within the life sciences industry, focusing on proteins, assay kits, media, or cell-based products.
  • Proven experience in leading QC for diverse product lines.
  • Strong knowledge of regulatory frameworks related to QC for biologics and diagnostics.
  • Experience with analytical method development and product testing validation.
  • Experience in leading teams and overseeing QC labs.

Nice-to-haves

  • Experience with ELISA, cell culture assays, mycoplasma testing, and sterility testing.
  • Proficiency in biochemistry, cell biology, media testing, and buffer performance.

Benefits

  • Competitive salary range of $130k-150k/yr
  • Opportunities for professional development and career growth.
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