QA Specialist

Devens, MA

Posted: 07/15/2022 Job Number: 21136044

Job Description

Position is hybrid - 50/50 - may fluctuate dependent on-site needs.

Project Description:
  • This role is responsible for managing inspection readiness and self-inspection activities for the Devens Cell Therapy Manufacturing Site located in Devens, MA.
  • This role will be interacting and supporting CTDO functions at our Devens site from a compliance perspective.
  • Specifically, partnering with different functions (i.E., Operations, Supply Chain, MS&T) to proactively identify compliance risks, develop collaborative solutions, and track effective resolution of actions to close compliance gaps.
  • Provides assistance in managing the day-to-day activities related to audits and inspections.
  • Coordinates and supports audit and inspection logistics at the site (scheduling of activities, planning, issuing agendas, reports etc.)
  • Participates actively during inspections and audits, including performing readiness exercises before and during inspections/audits.
  • Assists in the development, implementation, and maintenance of procedures for the site Compliance programs.
  • Prepares training materials on GMP Topics, including inspection readiness and audit management.
  • Assist in development of effective auditing tools and training aids.
  • Trains SMEs and support staff on specific roles, responsibilities, processes, and systems associated with inspection management and support.
  • Initiates and coordinates writing and on-time completion of regulatory commitments, responses, and other correspondence.
  • Collaborates with internal teams on key issues ensuring compliance with cGMP's and other regulations.
  • Identifies compliance risks and escalate issues to appropriate levels of management for resolution.

Required Skills:
  • Bachelor's degree or higher in life sciences, chemistry, engineering, or related field.
  • Minimum 5 years of experience.
  • Must have knowledge and experience with cGMP manufacturing, quality, and compliance as well as US and global cGMP requirements.
  • Experience with regulatory inspections and internal GMP audits.
  • Excellent verbal and written communication skills with ability to prepare written communications and communicate problems to management with clarity and accuracy.
  • Demonstrates a high degree of attention to detail, with strong documentation expertise.
  • Able to effectively multi-task and demonstrate strong organizational skills.
  • Possesses the ability to generate and present audit/quality metrics via PowerPoint/Excel.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Jennifer: jennifer@alphaconsulting.Com


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Jennifer Hernandez

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