QA Associate II, In-Plant
Company: AGC Biologics
Location: Seattle
Posted on: February 21, 2021
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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 www.agcbio.com.SummaryThe QA Associate II
(In Plant Operations) is responsible for providing (24/7/365)
Quality support to theactivities listed below at the Bothell
site.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
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