Quality Assurance Specialist I

Company: Integrated Resources, Inc.
Location: Cambridge
Posted on: May 11, 2022

Job Description:

Job Description
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 identified).
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 reports.
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.)
Education:
Bachelors Degree preferred.

Experience:
Pharmaceutical cGMP experience preferred.

Behavioral Competencies and Skills:
Strong computer skills and proficiency with Microsoft Office including Visio, Sharepoint, and industry standard Quality Management software.
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.

LICENSES/CERTIFICATIONS:
None required.

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).

TRAVEL REQUIREMENTS:
None required.

Keywords: Integrated Resources, Inc., Cambridge , Quality Assurance Specialist I, Other , Cambridge, Massachusetts