QA Associate II, In-Plant

Company: AGC Biologics
Location: Seattle
Posted on: February 20, 2021

Job Description:

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit .

Summary

The QA Associate II (In Plant Operations) is responsible for providing (24/7/365) Quality support to the
activities listed below at the Bothell site.

All applicants must be willing to work the following shifts:

6 PM to 4:30 AM Sun to Wed or Wed to Sat

6 PM to 6:30 AM

week 1- 3 days on (36 hour work week) / 4 days off

week 2- 4 days on (48 hour work week) / 3 days off

Principal Responsibilities

• Review of executed manufacturing batch records for completeness, compliance, and accuracy to support product lot disposition.
• Approve equipment cleaning and change over operations.
• Approve and execute area change over operations.
• Support approval and issuance of Master Batch Records (MBRs).
• Approve calibration and maintenance records for GMP operations.
• Participate in process improvement activities aimed to add efficiency to Quality processes.
• Collaborate in the resolution of issues associated with the manufacturing operations, with the QA point-ofcontact, to provide guidance and facilitate the resumption of manufacturing activities post deviation detection.
• This position will require scheduled weekend work and occasional night work to support Manufacturing, Quality Control, and Engineering Operations activities.
  
  Knowledge, Skills & Abilities
  
  • Technical and analytical understanding of Biologics Manufacturing and testing
  • Knowledge of regulatory compliance principles, strategy and rational as they relate to Biologics Manufacturing.
  • Good oral and written communication skills.
  • Good organizational skills.
  • Demonstrated experience in areas of teamwork and problem-solving.
  • Ability to work on moderately complex problems where analysis of situations or data requires an evaluation of factors. Understanding of basic scientific/technical concepts.
    
    Education/Experience
    
    • BS degree in Biology, Chemistry or other relevant discipline preferred.
    • Minimum 1 year of QA-related or 2 years of pharmaceutical/device manufacturing or Quality Control experience. Advanced degrees in Biology, Chemistry, or related discipline may substitute for work experience.
      AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Keywords: AGC Biologics, Seattle , QA Associate II, In-Plant, Professions , Seattle, Washington