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QUALITY ASSURANCE AUDITOR & COMPLIANCE SPECIALIST

  • Location: Massachusetts
  • Job Type:Contract

Posted about 1 month ago

  • Expiry Date: 16 August 2022
  • Referral: 212581@accuick.com

Job Description:    

Comments:

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

  • 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 and other regulations

  • Identifies compliance risks and escalate issues to appropriate levels of management for resolution

Qualifications:

  • 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.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Contact:

Full Name: Savita Khashu

Email ID: savitak@askconsulting.com

Phone: 470-483-1052