Quality Control Lead

Company: Bayside Solutions
Location: Redwood City
Posted on: February 20, 2021

Job Description:

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. "I have been very impressed with how quickly Bayside has been able to mobilize a team (twice) to help us with the design work for International. "With a tight deadline... Read more -- Director, IT - Global Retail Organization "I've had the privilege of working with Bayside Solutions for several years. Bayside Solutions have consistently been my "go-to" people to fill positions as they provide me with quality candidates... Read more -- Human Resources Manager Pharmaceutical Corporation "Bayside Solutions has been a great resource supporting our rapid growth. Their team has always provided timely feedback, making the hiring process extremely easy and fast. They have provided exceptional... Read more -- Director of Engineering - Renewable Energy EPC

Keywords: Bayside Solutions, Redwood City , Quality Control Lead, Other , Redwood City, California