Job Number: 21136044
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's 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.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Jennifer: jennifer@alphaconsulting.Com
ALPHA'S REQUIREMENT #22-02155
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE