Quality Operations Specialist I

Enzene INC•Pennington, NJ

About The Position

Under the oversight of the Quality Operations Manager, this position will be responsible for providing quality oversight and operational support for US QA functions, including document review, deviation management, change control, audit support, and QMS reporting. This role will liaise closely with cross-functional teams in both India and the US to ensure compliance with cGMP and FDA regulations.

Requirements

Bachelor's degree preferred in Life Science, Science or Regulatory related field and/or equivalent experience
Minimum of 1-2 years within GMP industry; related experience and/or training. experience in Pharmaceutical Quality Assurance/Compliance or additional education with knowledge of cGMP regulations. Internal and External (QA/Regulatory) Audit experience preferred. Master Control experience preferred
Proficient knowledge of GMP’s, FDA regulations and documentation procedures required, thorough knowledge of cGMP regulations, quality systems and regulatory requirements, Proficiency/knowledge with electronic management systems (such as QDMS, LMS, EDMS, and E-Doc) Advanced skills with MS Office applications and Adobe Acrobat, experience with Biotech startup environments.
Comfortable and able to operate in a multi-cultural, multi-site environment. Able to communicate system implementation status for senior leadership. Able to explain application of cGMP regulations, quality systems and regulatory requirements for documentation system. Able to work professionally & productively in an open office environment.

Responsibilities

Review of completed GMP records (production records, cleaning records, Quality Control assay records, etc)
Participate in assigned operational Quality Risk and Compliance (QRC) activities
Support of inspection readiness (IR), tracking and closure of IR actions across multiple parallel workstreams, assist with meeting minutes, scheduling of meetings, trainings, process improvement, quality metrics
Manage updates to Good Manufacturing Practices (GMP) SME Lists for Inspections
Participate in Deviation, Corrective and Preventive Actions (CAPA) closure and completion of lessons learned in conjunction with Manufacturing personnel.
Follow-up on training due for area of responsibility
Compile data from systems for metrics generation as requested
Other Quality Operations Support to include Quality on the Floor activities and real time deviation initiation.
Tracking of new and revised controlled documents – follow ups with curricula owners on training changes,
Participate in quality related training workshops
Other duties as assigned.