R.A. Wylan & Co. Inc.,
Career Center

Supervisor, Quality Assurance Documentation

Location: Somerset, NJ
Job Type: Direct Hire
Salary: $65,000.00 - $75,000.00
Date: 2/13/2018
Job ID: 02566320
Job Description
Specialty Pharmaceutical company is expanding the Somerset, NJ location- Looking for a Supervisor, QA Documentation
This position serves as a dedicated resource for the administration of controlled documentation and documentation systems at the companys Somerset site. Associated documentation, systems and activities provide support for all facets of material, process and product development, validation, manufacture, testing, storage, service and distribution. It also applies to controlled documentation associated with employee training, facility/utility/equipment descriptions, calibration and maintenance, as well as associated documentation processing mechanisms (e.g. change control, archiving, storage, etc.) 

ESSENTIAL FUNCTIONS:
Include the following. Other duties may be assigned.
  • Administer document control system.
  • Supervise daily activities of two document specialists
  • Issue batch production and control records to manufacturing after assuring that each record is a
true copy of the Master Batch Record.
  • Process Document Change Requests including the following:
  • Assign document numbers
  • Edit, prepare, process and distribute controlled documents
  • Retrieve obsolete SOPS
  • Prepare and maintain SOP index
  • Edit and maintain a Tracking Log for DCRs
  • Assign Document Change Request (DCR) tracking numbers
  • Ensure DCR’s are circulated to appropriate reviewers for approval
  • Maintain appropriate Tracking Logs and databases.
  • Provide documents and document change control data for change controls, annual product
reviews, regulatory submissions and annual reports.
  • Provide information to the training group for the evaluation of required training for all employees relating to the Document System.
ADDITIONAL RESPONSIBILITIES:

Responsibilities include interviewing, hiring, training, planning, assigning and directing work, appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems. 


QualificationsQUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.