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Abzena · 19 hours ago

QA Training Manager

San Diego, CA

Full-time

Onsite

Mid, Senior Level

$100K/yr - $150K/yr

7+ years exp

Abzena is a company dedicated to quality excellence in the development of biologics and bioconjugates. The QA Training Manager will lead the Document Control and Training teams, ensuring compliance with regulatory requirements while facilitating the delivery of training and documentation to meet departmental goals.

BiopharmaBiotechnologyLife SciencePharmaceutical

Hiring Manager

Bri Copeland

Responsibilities

Directly responsible for leadership of the Document Control and Training teams and functions

Manage the document management and training program

Strategically partner with Quality leadership to facilitate short-term and long-term Quality initiatives

Collaborate with Quality leadership and departmental stakeholders to ensure accurate and timely delivery of documents and training to ensure regulatory, global, site, and departmental goals and requirements are maintained and met

Directly lead as well as perform, execute, and assist in the execution of daily tasks in the Document Control and Training areas

Operate in both a team and individual setting

Facilitate the review, processing, and maintenance of the global Document Control system through:

Organization, maintenance, and archival of controlled documents

Writing, reviewing/revising, approving, and processing Standard Operating Procedure (SOP), Batch Record, Protocol, and equivalent documents through the Document Control system

Issuance of document, part, lot, and investigation numbers

Issuance and review of electronic and paper based GMP logbooks

Maintain the status of Document Control workflows to drive on time completion

Evaluate document management and training quality processes for continuous improvement

Provide Document Control and Training Quality metric as required

Update Quality Systems tracking tools as required

Assist in the QMS and CSV qualification activities as required

Conduct internal audits of the document control and training processes

Provide customer communication and customer audit processes related to document control

Collaborates with site personnel to drive consistency in quality process execution

Execute and maintain Electronic Management Systems as it relates to document control

Accomplishes department objectives by managing staff

Plans and evaluates department policies, processes, priorities, and performance goals

Motivates direct reports by providing positive feedback and skills development

Develops, coordinates, and enforces systems, policies, procedures, and productivity standards

Acts as a liaison with senior level management and other department managers by developing productive, collaborative relationships and utilizing clear and effective communication

Regularly review performance metrics

Make strategy adjustments as necessary

Qualification

Quality AssuranceGMP regulationsDocument ControlPeople leadershipRegulatory inspectionsMicrosoft OfficeMulti-taskingWritten communicationVerbal communicationOrganizational skills

Required

BS/BA degree, preferably in science

Minimum Seven (7) years of experience in Quality Assurance within a GMP oriented/regulated environment. Three (3) to Five (5) years of direct people leadership experience

Demonstrated ability to perform under pressure, work independently, multi-task, and organizational skills

Excellent written and verbal communication skills

Experience in regulatory/health authority inspections, client and internal audits

Knowledge of GMP regulations, good documentation practices, cGMP, 21CFR, EU GMP, and other applicable regulations, standards, and guidance

Demonstrated ability to successfully interface and collaborate with a multi-discipline team

Must be familiar with Microsoft Office applications

Operates to the highest ethical and moral standards

Exhibits professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices