QA Systems Associate Document Control at HAYS in Raleigh, North Carolina

Job Description:

POSITION SUMMARY:


Under the direction of the QA Document Control Supervisor, the QA Systems Associate - Document Control will


Be responsible for searching, reviewing, comparing and verifying data using Excel spreadsheet, Master Control, and SAP OpenText.


This individual will work closely with the IT Validation team for the purpose of data review and for


Migration process. This individual will have working knowledge of the document management life-cycle.


Responsibilities:

• Maintain quality system controls to ensure a state of compliance


• Take appropriate steps to reduce waste and losses in the process.


• Under the guidance of the QA Document Control Supervisor, the QA Systems Associate - Document Control will:

Be a liaison between QA DC and the IT Validation Team for the purpose of reviewing, correcting, coordinating, and communicating issues relating to the DMS validation project:

• Review Excel data against set criteria


• Search and edit in MasterControl


• Perform document review against set criteria/protocol


• Execute activities within the Document Management Systems in a compliant manner

• Other duties as required


• Support all cross-functional teams within the site for document control related needs


• Maintain documents per guidelines to ensure quick retrieval


• Assist in implementing systems to enhance the document management process and daily operation.

Education :


Associates degree in scientific discipline or closely related technical field of study preferred


High School Diploma required


Experience :


•
2-5 years of


Pharmaceutical and FDA/GMP industry experience is preferred.


•
Previous quality experience is preferred.


•
Any IT quality certification is a plus.


Knowledge and Skills :


• Excellent computer skills with knowledge of Microsoft programs, particularly Excel, and Word.


Knowledge of MasterControl, Documentum, SAP OpenText, Trackwise, is a plus.


I must be proactive, results oriented, with a strong attention to detail.


•
A self-starter with a good work ethic and the ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.


•
The ability to manage multiple projects simultaneously, meet deadlines.


•
Excellent verbal and written communication.
Must be able to read, write, and speak English


•
Strong organizational, troubleshooting and problem-solving skills.
Ability to analyze details and perform structured decision-making on a daily basis.


•
Strong interpersonal skills with ability to interact with all levels of personnel professionally


•
Good communications skills



What you need to do now


If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.


If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.


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