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Job Details


Quest Diagnostics

Quality Assurance Specialist -Document Control (req91542)

Healthcare

All

Yearly

Full Time

No

Marlborough, Massachusetts, United States

Job Description

Position: Quality Control Specialist -Document Control

Location: Marlborough, MA

Schedule: M-F

SUMMARY

Document Control Activities:
Management of the Document Control System
Management of the Electronic Document Management System
Maintenance of the master Documentation System
Overseeing the maintenance of electronic Training Records for all QSR employees
Maintenance of the Non-conformance, Change Control, Complain and Feedback Handling Logs
Compilation of QA documentation in accordance with QSR and written procedures including testing records, calibration records, training records and quality records, as required
Verifying DCR submissions for accuracy and completeness.
Providing copies of documents, as requested.
Formatting and word-processing documents submitted to Document Control, as necessary.
Interacting with area management on all aspects of document control issues, including uer management and document issuance.
Performing other duties as assigned.
Quality Systems Activities:
Assisting in the investigation of non-conformances and the implementation of Corrective and Preventative actions.
Assisting in investigation and review of customer complaints.
Verification of QC results and the daily result activities as required.
Performing in-process inspection as required in manufacturing runs as required.
Issuing and review of batch documentation.
Release of incoming goods, components and finished goods.
Performing and assisting in internal quality audits and supplier audits.
Assisting in regulatory affairs issues.
Assisting in the preparation for, and execution of external and 3rd party audits.
Participating in, and contributing to, major site development projects.

Job Requirements:
Bachelors degree in Science or related area preferred
At least 2-3 years related experience in a QSR manufacturing environment.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.
The ability to write routine reports and correspondences.
The ability to speak effectively before groups of customers or employees.