Quality Control Lead

Redwood City, CA 94063

Posted: 10/22/2020 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 18073

Job Description

What You’ ll Do
  • Review executed QC test records for product release, including the investigation and resolution of deviations, OOS and OOT observations.
  • Perform routine QC testing as needed
  • Write, organize and review QC analytical result tables, protocols and reports.
  • Work in conjunction with Assay Development department to qualify, validate and transfer QC analytical methods as applicable
  • Manage and build sample control processes for GMP release, stability, and/or additional test samples
  • Lead routine cell culture, reagent preparation, and other laboratory testing support activities
  • Lead and/or review equipment/instrument IOQ/PQ (vendor)
  • Implement and manage equipment/instrument maintenance/calibration
  • Work with QC management to identify and mitigate risks to meeting QC milestones and goals.
  • Coordinate with the Quality Assurance department for required review and approval of documents
  • Oversee and provide direction to the direct reports under the guidance of the QC Management

About You
  • 5 to 7 years in a GMP environment (pharmaceutical or biotechnology industry) 
  • Solid knowledge and understanding of US and international regulations and guidance applicable to Quality Control and method validation
  • Experience in quality control required.   A strong background in molecular biology is desired.
  • Experience transferring assays from Assay Development to Quality Control is required.
  • Experience in assay qualification and validation strongly desired. Experience with  viral  vector (adeno-associated virus) product is a plus.
  • Experience with adherent and suspension cell culture is required. Experience with HEK293 and Sf9 cells is a plus.
  • Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries required. Must have laboratory experience with a variety of analytical techniques including, but not limited to, quantitative PCR, ELISA, and cell-based methods.
  • Knowledge of statistical methods applicable to the analysis of data. 
  • Proficient in general and non-routine laboratory skills.
  • Experience working with contract testing labs. 
  • Excellent interpersonal, communication and organizational skills.
  • Flexibility in  problem solving, providing direction and work hours to meet business objectives. Good oral and written communication skills. MS Office skills; equipment related software such as  Soft Max  Pro desired.

Meet Your Recruiter

Felicia Id-Deen

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