GMP Sr. Specialist, Quality Assurance (Lot Disposition), Tustin, CA
Posted on: May 2, 2021
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
- Review of testing documentation from Microbiology and Chemistry
- Compilation and QA Review of all records in Batch history
- Issue, verify and file documents relating to processes,
equipment, facilities and utilities in the manufacture of product.
- 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
- Must have flexibility in problem solving and work hours to meet
- 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
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