Doc Control

East Bay, (none selected) | Contract

Post Date: 11/10/2015 Job ID: 3002 Industry: General

Position Title: Sr. Document Control Specialist

 

Reports to: Quality System Supervisor

 

Department: Quality

 

Original Issue Date: TBD

 

FLSA Status: Exempt

 

 

PURPOSE OF JOB:

Perform Document Control and Record Control activities, and provide administrative support for the Company’s Quality System.

 

MAJOR DUTIES AND RESPONSIBILITIES:

* Provide full Document Control and Training administrative support.

* Manage Change Orders (COs) in a timely manner with high level of accuracy in compliance with company procedures.

* Collaborate with Change Order Initiators to ensure accuracy of the change orders.

* Maintain External Standards List.

* Support metrics creation and data collection.

* Ensure compliance with controlled document format and content.

* Maintain Document Control and Quality System related databases and logs (e.g. issuance of part/document numbers, laboratory notebooks).

* Implement improvements to Document Control and Training systems and procedures.

* Perform distribution of controlled documents and retrieval of obsolete/superseded documents.

* Periodically inspect/audit controlled binders and training records to ensure accurate distribution and current training (i.e. correct documents and current revisions).

* Support internal and external audits as well as CAPA activities

* Issue log books and lab notebooks as needed

* Scanning, filing and maintenance of all types of quality system records.

* Assist with software validation including executing software test scripts

* Maintain training records and training database as needed.

* Perform other Quality System related duties as assigned.

EDUCATION REQUIREMENTS:

* Bachelor’s degree or equivalent industry experience with associate degree preferred.

 

EXPERIENCE REQUIREMENTS:

* Minimum of 7 years of Document Control experience in medical device, pharmaceutical, or related industry.

 

OTHER QUALIFICATIONS:

* Must be proficient with WORD, Excel, Power Point and Adobe.

* Skilled in in technical writing and SolidWorks

* Must be organized and have strong attention to detail.

* Excellent communication and time management skills required.

* Work well with cross functional teams

* Work independently with minimum supervision

* Ability to learn quickly and prioritize tasks in a fast paced and dynamic environment.

* Knowledge of FDA QSR/cGMP/ ISO 13485 is required.

* Proficiency with Electronic Document Management systems is required.


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