Company: Katalyst Healthcares & Life Sciences
Posted on: March 20, 2023
Job Description :
- Responsible for the day to day activities including execution,
- vendor management, issues, deviations, corrections and
remediation efforts for facility, equipment, systems, and processes
in support of personalized cell therapy production according to
- Work in a collaborative team setting with Quality,
Manufacturing Operations, Facilities & Engineering Quality Control,
Operations Technical Support, Supply Chain and Planning.
Roles & Responsibilities :
- Executes the commissioning, qualification, requalification,
validation and any associated maintenance activities within the
- Manages multiple and complex CQV projects, provides status
reports and coordinates with other departments or outside
contractors/vendors to complete tasks.
- Supports and/or owns technical and quality investigations,
CAPAs and corrections.
- Develops and performs any required remediation efforts and
associated CAPA plans.
- Authors, owns and executes master and completed CQV protocols,
summary reports and associated data for conformance to regulations,
SOPs, specifications and other applicable acceptance criteria,
specifically data integrity.
- Executes, owns, assesses, and participates in the creation,
revision and review of change controls, SOPs, and other
- Participates in authoring Risk Assessments, FMEAs, Periodic
Qualifications, Project Plans, Master Plans, and Annual Product
Education & Experience :
- Knowledge of cGMP regulations and FDA/EU guidance related to
manufacturing of cell-based products as well as knowledge of Good
- Strong interpersonal and written/oral communication
- Ability to quickly process complex information and often make
critical decisions with limited information.
- Proficient in applying process excellence tools and
- Ability to independently be responsible for a portfolio of
- Ability to pay attention to details and follow the
- The candidate must be highly organized and capable of working
in a team environment with a positive attitude under some
- Good written and verbal communication skills are
- Ability to summarize and present results, and experience with
team-based collaborations is a requirement.
- Ability to work with others in a team environment.
- Detailed knowledge and understanding of current Good
Manufacturing Practices (cGMP) and current Good Tissue Practices
(cGTP) related to CAR-T manufacturing or cell processing.
- Ability to identify/remediate gaps in processes or
- Experience with ICH and/or 21 CFR parts 210, 211, 1271 is
required and 600, 601, and 610 is preferred.
- Experience authoring and executing documentation including but
not limited to: Batch Records, SOPs, Work Instructions, CQV
- Experience with TrackWise, CMMS and Maximo
- Proficient with using Microsoft Office applications (Outlook,
Excel, Word, and Powerpoint).
- Experience working in an aseptic manufacturing facility,
preferably cell therapy, testing facility, quality assurance, or
- Demonstrated ability to work independently, drive effective
communication, coordination, and collaboration across relevant
cross functional groups to establish a strong, compliant CQV
program to enable robust production, testing and release of product
Keywords: Katalyst Healthcares & Life Sciences, Trenton , CQV Specialist, Other , Raritan, New Jersey
Didn't find what you're looking for? Search again!
Loading more jobs...