What are the responsibilities and job description for the Clinical Quality Assurance Specialist position at Actalent?
Description:
TOP Clinical Research Company in the Nation!
MUST have experience with biologics and authoring CAPAs/deviations!
Major and critical deviations and investigations
Facilitate meeting with functional areas with higher level personnel to drive closure of records
Monitoring of mailbox- 1-3 events a day
Need deviation, investigation, CAPA experience is a must
20% administrative (meetings, SOP reading, notes, etc.)
80% deviation, investigation, CAPA
Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
Participates in developing Standard Operating Procedures to ensure quality objectives are met.
Facilitate, review, and approve major and minor investigations related to GxP operations.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.
Develops solutions to more complex problems, identifies variance from accepted practice, and evaluates impact as necessary.
Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks.
May assist with compliance audits as required.
Facilitate cross-functional meetings with internal and external parties as required.
Apply Root Cause Analysis tools to identify root causes and propose effective corrective and preventive actions.
Supports management review process through development and generation of quality system metrics and trending, and escalate issues as required.
Supports the maintenance and improvement to quality systems processes, as needed
Participate in the development of training programs regarding all aspects of producing quality products, as required.
Assist compliance audits and provide SME support as required for regulatory inspections.
Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
Qualifications
Pharmaceutical experience is a MUST 3-5 years
Technical witting of deviations/investigations required
Biologics experience required
TrackWise/Veeva Vault
Aptitude and openness to learning
Prior QA experience required
Open communicator
Time management
Critical thinking skills
*please note this is NOT a QA Engineering role, it is in the clinical research space and experience is not transferrable
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
