DC Specialist

Job description

JOB DESCRIPTION:

MAIN PURPOSE OF ROLE

·  Function as a Subject Matter Expert for Site Document and Record Control processes. Develop, implement, administer, coordinate, maintain, and secure controlled documents to ensure process and product related documentation meets operational needs and conforms to company standards as part of the change control process. The position provides insight to the Site and Division with regard to capabilities and requirements of Document Control; including Change Control. Serve as compliance SME with regard to Change Control. Reviews and provides guidance to internal customers to ensure sound decisions are being made regarding Change Control. Ensures change packages within Document Control are processed in a timely manner. Maintain the archival of quality records, including electronic records imaging system, laboratory notebooks, and the archiving/storage and/or retrieval of off-site documentation. Coordinate training requirements of new and revised procedures with process owners and interface with electronic training system (e.g. Pilgrim) to launch training. Collects; prepares and reports Doc Control Department business metrics.

MAIN RESPONSIBILITIES

Additional Main Responsibilities from Legacy System

·  Performs daily job functions under minimal supervision of exempt level personnel.
·  Develops optimal methods for achieving goals.
·  Manages own time and may oversee the work of others.
·  Operates independently and some activities are project and goal related.
·  May check or audit the work of others in the same function.
·  Handles all tasks efficiently. applies functional knowledge to the introduction of new processes.
·  Tests and pilots new processes and procedures.
·  Documentation Responsibilities: Establish new and modify existing documentation in a manner which will achieve accuracy and avoid errors and potential product recalls or issues.
·  Other Project Responsibilities: Assist in various documentation projects.
·  Provide independent support for other Projects.
·  Plan and execute projects as assigned.
·  Identify areas for improvement and implement necessary changes.
·  Other Project Responsibilities: Leads or assists in the training of new employees to new or establishes Document Control related projects.
·  Serve as a technical advisor.
·  Quality Responsibilities: Conform to the Quality System.
·  Identify Quality improvements and develop suitable corrective actions.
·  Implement Quality improvement projects and other job duties as assigned.

Accountability/Scope/Budget from Legacy System

·  Make decisions related to the day to day responsibilities of the position without prior review with immediate manager; appropriately escalates matters.
·  Make recommendations and review with immediate manager in cases where potential direct impact of customer or outside organizations may be involved.
·  Understands when a decision to be made is outside scope of authority and be able to effectively communicate to appropriate level for resolution.
·  Employee is accountable for the timely implementation of all documentation necessary to complete tasks.
·  To minimize errors which could negatively impact product or product documentation; accuracy and attention to detail is expected.
·  To minimize errors and associated risks; the employee is expected to effectively utilize Quality Systems and follow all applicable operating procedures.
·  Employee should be able to analyze alternative courses of action in relation to desired goal; articulate those actions to management; examine risk in relation to procedures and take appropriate action.
·  Tasks performed are frequently associated with product availability and quality issues.
·  Position requires some risk taking skills.

QUALIFICATIONS

·  Bachelor degree  
·  Requires knowledge of ISO 9001, ISO 13485 or 21CFR820.
·  2 - 3 years experience in an regulated environment, Quality Control; Document Control; Compliance; Auditing; Engineering or Regulatory and 1 to 3 years of experience as a Subject Matter Expert in the field of Document and Change Control.

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Administrative Support

     

DIVISION:

        

LOCATION:

China > Hangzhou : #198 12th Street, Hangzhou Economic & Technological Development Area

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable