This site uses cookies. To find out more, see our Cookies Policy

QA Manager in West Caldwell, NJ at Synerfac

Date Posted: 9/30/2018

Job Snapshot

Job Description

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITY

The right candidate has managed a QA Documentation team..
This person is in charge of the process that creates documents and control of the process.
Will be managing 2 people.


Responsible for the GMP Document Control System that includes:
•Quality Assurance documentation system: life-cycle of documents (creation, distribution, revision, review cycle, implementation) including periodic review cycles.
•Document Change Control system
•Site wide logbook lifecycle process
•Site’s Retention Schedule and Archival Process to ensure that documents are appropriately retained, retrievable and destroyed
•Manage the process for the filing and retrieval of completed Training Records.
•Supervision of a team of Documentation Specialists. Responsible to allocate workload, provide objective setting and performance review discussions.

Job Requirements

REQUIREMENTS:
•BA or BS degree in a scientific discipline.
•At least 10 years of experience in cGMPs at an operational level supporting manufacturing or testing in a pharmaceutical environment with an additional minimum of 5 years of experience in a direct QA Documentation function working within / responsible for Quality Systems
•Knowledge of GMP, USP, EP, and CFR requirements and regulations
•At least 3 years of experience directly supervising direct reports