Quality Assurance Specialist I
Company: Integrated Resources, Inc.
Posted on: May 11, 2022
Position Title: USA Quality Assurance Specialist I
Function: R&D Quality
Department: R&D Quality
OBJECTIVE: (Briefly summarize the overall purpose of the position.
Objectives should be written in 3 4 bulleted statements).
The USA Quality Assurance Specialist I supports strategic cGMP QA
activities associated with clients internal GMP cell therapies
manufacturing facility on-site in Cambridge, MA, USA.
This position supports clients Quality operations focused on
electronic and paper-based document and training lifecycle
management, and raw material inspection and release.
ACCOUNTABILITIES: (Describe the primary duties and responsibilities
of the job. Approximately 5 10 bulleted task statements ashould be
Responsible for on-site lifecycle management of cGMP electronic and
paper-based documents and executed records within the clients
Learning and Document Management system.
Responsible for paper-based cGMP final review, scanning, on-site
archival, and off-site storage. Responsible of issuance,
distribution, reviewing, scanning, and archiving of documents such
as batch records, forms, logbooks, records, protocols and
Responsible for inspecting and releasing of raw materials for use
in on-site production.
Effectively interact with the quality team and internal
stakeholders to support the development, manufacturing, testing,
packaging and release of cell therapy products.
Support the CTMF team as needed.
Additional duties as assigned.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: (List the education
and competency requirements to perform the primary responsibilities
of the job. Minimum requirements must be clearly stated.)
Bachelors Degree preferred.
Pharmaceutical cGMP experience preferred.
Behavioral Competencies and Skills:
Strong computer skills and proficiency with Microsoft Office
including Visio, Sharepoint, and industry standard Quality
Demonstrated teamwork, initiative, and problem-solving skills.
Strong oral/written communication skills.
Highly organized and high attention to detail.
Highly flexible and very adaptable in a high pace environment.
PHYSICAL DEMANDS: (Identify any physical demands required in the
performance of the primary responsibilities of the position).
Routine demands of an office based environment.
This role supports biopharmaceutical production operations
therefore the work environment includes exposure to production and
processing facilities, as well as analytical testing laboratories
(this list is not exhaustive).
Keywords: Integrated Resources, Inc., Cambridge , Quality Assurance Specialist I, Other , Cambridge, Massachusetts
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