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The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Essential Functions and Responsibilities
Schedules batch record process for all floor associates in accordance with kitting schedule.
Facilitates internal training on quality assurance requirements, processes, and procedures.
Provides technical expertise to the client services team on tech transfer activities.
Provides supportive documents to investigators and/or compliance team.
Conducts final verification of batch records prior to archiving; sends records to document control; Review of executed APS reports/ batch records.
Draft SOPs, WIs, and Forms for revision.
Supports QA teams with continuous improvements initiatives to enforce quality culture.
Initiate change control as required.
Assist gathering information for internal and external (e.g. cGMP, client, regulatory agencies) audits.
Support walk thru in preparation for internal and external (e.g. cGMP, client, regulatory agencies) audits.
Other duties as assigned.
Qualifications
Bachelor of Science in biological sciences or other relevant field of study
Minimum 5 years' experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics. Working knowledge and technical understanding of aseptic manufacture of biologics
Experience in both clinical and commercial manufacturing is preferred.
Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. etc).
Experience in organizing teams for effective and timely completion of projects.
Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
Experience participating in or hosting health authority inspections and/or client audits.
Competencies/Candidate Profile
Relevant computer skills (Microsoft Office, Outlook)
Detail-oriented and organized
Analytical and problem-solving skills
Good written and oral communication skills
Ability to multi-task and be adaptable
Flexible and able to adapt to company growth and evolving responsibilities
Ability to work independently and with a team
Strong Project Management and organization skills
Supervisory Responsibilities
Indirectly supervises QA Associates I and II within the Quality Assurance department
Team lead for 2-3 QA Associates 1 & II
Minimum Required Training to Be Completed within the first 90 Days of hire
GXP training
SOP & WI training
Safety Training
Working Environment
Must have the ability to work in a team-oriented environment and with clients
Must be able to work during the weekend, holidays and as required by the company
May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc.
Understanding of quality system applications
Must be able to handle the standard/moderate noise of the manufacturing facility
Amtex Systems Inc
