QA Manager (Documentation)

Location
Essex County, NJ
Posted
Mar 27, 2018
Ref
4819
Required Education
Bachelors Degree
Position Type
Full time

JOB TITLE:          QA Manager

DEPARTMENT:    Quality Assurance

REPORTING TO:   Director, QA

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIY

           

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.

 

 

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