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QA Manager (Documentation) in West Caldwell, NJ at Volt

Date Posted: 12/1/2018

Job Snapshot

  • Employee Type:
    Direct Hire
  • Job Type:
  • Duration:
    N/A
  • Date Posted:
    12/1/2018
  • Job ID:
    140937
  • Pay Rate
    $0.0 - $115000.0/Year
  • Contact Name
    Volt Branch

Job Description

Position: QA Manager of GMP Documentation

Location: West Caldwell, NJ 07006

Status: Direct Hire

We are seeking this position for a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems.

This is a unique opportunity for an individual with a combination of the required experience in Quality Systems in an FDA Regulated Industry along with a demonstrated history of leading complex projects and a track record of continuous improvement. 

RESPONSIBILITIES:

  • 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

Please apply to position or contact Nikki Jaiswal at 714 283 7388 for any questions and more details regarding this position.

Volt has been serving some of the nation's strongest companies for over 60 years. As a Volt employee, you can expect the highest level of on-site support. We have a long-standing tradition of developing lasting and mutually beneficial relationships with its employees.

Volt is an Equal Opportunity Employer.