Document Control Specialist

New York, NY | Contract

Post Date: 09/27/2017 Job ID: 4002 Industry: Software/Hardware
JOB TITLE:  Document Control Specialist - CONTRACT


DEPARTMENT:  Quality Assurance
 
JOB SUMMARY

Responsible for executing required QA review activities for change control elements associated with local and global departments in support of the Quality Management System. Will revise and create Standard Operating Procedures (SOP’s), Work Instructions (WI's) and other controlled documents in collaboration with process owners and subject matter experts. Will utilize the Agile electronic Quality Management System (eQMS) to process these documents and obtain approvals as well as review Change Orders and support training. May participate in establishing procedures for local and global review of change packages as well as engineering changes, engineering studies, and validations when necessary.  May assist with the investigation of Quality Feedback (QFB’s), and Non Conformance Reports (NCR’s) or other sources of quality data.  May participate with packaging verification and validations when necessary.       
 
ESSENTIAL FUNCTIONS
  • Support Global Packaging and Global Supply Chain from QA review perspective for Packaging and New Product Launch Change Orders (PCO and PRCO) and provide guidance on requirements to ensure compliance with change control regulations and the company's policies and procedures.
  • Act as change analyst for Document Change Orders (DCO’s) and Deviations for all controlled documents within assigned departments.
  • Manages Training positions and roles in Agile for assigned local and Global departments.
  • Provides QA oversight to Supplier Non-Conformances (SNC’s) generated by Customer Service.
  • May assist management with review and approval of corrective and preventative action (CAPA , Nonconformance Reports (NCR), and Quality Feedbacks (QFB)).
  • May assist with process audits to verify conformance with standard operating procedures. This will include revising and or creating SOP as directed.
  • Regularly provides status and updates to QA Management.
  • Generate or contribute to monthly reports provided to various departments and quality leadership as requested.
  • Communicates information effectively from other departments to the QA team.
  • Applies knowledge of Good Manufacturing Practices (GMP) regulations and industry standards as well as ISO general guidelines.
  • Data entry and analysis into computer based collection systems (Access, Excel & Agile).
  • Ensures that all necessary reports are completed in a timely manner.
  • Performs archiving as necessary as it applies to quality records. May assist in all aspects of record retention and retrieval. May act as Administrator for record retention activities.
  • Perform or facilitate annual Quality Systems Regulation (QSR) retraining as required by the quality management system.
  • As business needs dictate, works extended hours to complete daily department goals or tasks, to include mandatory overtime.
  • Performs other assignments related to the department as directed by Leadership.


POSITION QUALIFICATIONS
Minimum Education
  • HS diploma required, Associates degree or equivalent combination of education and experience required.
  • 3 years experience with document control (NCR, QFB, SOP) required - Medical Device industry experience preferred, other regulated industry experience considered

Required Skills: (Knowledge, Certificates, Licenses, Software)
 
  • Working of knowledge of Microsoft Office Suite. Experience with Agile preferred. 
  • Should possess skills to utilize the concept of continuous improvement, change management and employee teams. Ability to work with a diverse workforce. 
  • Knowledge of Quality Assurance regulations and methodologies, including Good Documentation Practices.

Work Environment
 
  • Normal Office environment
  • Ability to perform light to medium physical work and standing for long periods of time, if required depending on the task

 
 
 

 
 
Affirmative Action/Equal Opportunity Employer. Minority/Female/Disability/Veteran 

Job

: Quality Assurance 

Primary Location

: United States-New York-Rochester 

Organization

: Quality Assurance 

Schedule

: Full-time 

Unposting Date

: Ongoing

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