- Expiry Date: 16 August 2022
- Referral: email@example.com
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
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.
Full Name: Savita Khashu
Email ID: firstname.lastname@example.org