GMP Sr. Specialist, Quality Assurance (Lot Disposition), Tustin, CA

Company: Kelly
Location: Tustin
Posted on: May 2, 2021

Job Description:

GMP Sr. Specialist, Quality Assurance (Lot Disposition), Tustin, CA Position Type: Direct Hire Summary: The Sr. Quality Assurance Specialist is an individual contributor who solves a variety of issues following cGMP regulations and company standards. Essential Duties and Responsibilities:

• Coordinate the release of API batches and lots.
• Release of Manufacturing Buffers and Formulations.
• Assist with discrepancy investigations.
• Review of Manufacturing Batch Production Records - Must have at least 4 years or more experience.
• Sign documents for activities as authorized and described by company policies, procedures and job descriptions.
• Collaborate with departments to ensure that all review activities are executed efficiently per governing SOPs.
• Serve as a technical subject matter expert (SME) in support of department functions.
• Review of testing documentation from Microbiology and Chemistry groups.
• Compilation and QA Review of all records in Batch history records.
• Issue, verify and file documents relating to processes, equipment, facilities and utilities in the manufacture of product. Qualifications:
  • B.S. degree in a Science discipline.
  • Require a minimum 4-6 years of experience in Manufacturing Batch Production Records review.
  • Must be able to interpret Quality standards for implementation.
  • Must have flexibility in problem solving and work hours to meet business objectives.
  • Require the ability to communicate clearly and professionally both in writing and verbally.
  • Skills to independently evaluate situations and propose potential solutions are essential.
  • Knowledge of cGMPs or equivalent regulations is preferred.
  • Industry experience working for a Contract Development and Manufacturing Organization (CDMO) is highly desirable. For Immediate Consideration, Apply Today! Questions? Call Grace at , Email at , or schedule a time to connect directly follow the link: Why Kelly -- ? Kelly-- Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly -- At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ]]

Keywords: Kelly, Tustin , GMP Sr. Specialist, Quality Assurance (Lot Disposition), Tustin, CA, Other , Tustin, California