Ref No.: 18-09101
Location: York, Pennsylvania
Start Date: 07/25/2018
Responsible for the establishment and maintenance of the document control system.

Prior to circulating for approval, work with document initiators to assure proper formatting, spelling and clarity of text for any written documents submitted to document control.
Track approval process and follow-up with initiator to assure all approval in a timely fashion.
Confirm that all edits are made appropriately in new and revised documentation after approval and prior to releasing for use.
Maintains all standard operating procedures, work instructions, forms, product labeling files, etc. in accordance with all facility and corporate procedures.
Maintains revision and approval status of all documents
Maintains hard copies of all approved documentation
Maintains appropriate form templates for access from company intranet & SharePoint sites.
Updates computerized documents with data from change control documents and maintains archive of changed controlled documents and labeling.
Act as contact point for Corporate for the issuance of new or revised corporate policies and procedures and provides notification to affected departments.
Coordinates the annual review of all controlled documentation, per procedure.

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

Education: A high school diploma required. Bachelor's degree preferred, or minimum 3-5 years' experience in Quality within an FDA regulated industry.
ASQ certification as a Quality Inspector or Quality Technician (or similar) highly preferred
ASQ certification as a Biomedical Auditor (or similar) preferred
Experience with performing product defect / complaint investigations, including identifying root cause or experience in inspection techniques manufacturing processes.
Experience with Corrective & Preventive Action (CAPA) systems
Knowledge of FDA Quality System Requirements and ISO 13485 Quality Standards
Ability to conduct Quality System Audits
Ability to analyze complex issues, conduct root cause investigations, and prepare reports on findings.
Experience working in Oracle, Agile and TrackWise systems preferred.
Must be able to observe company policies and safety procedures at all times.
Must be able to read and write in English. Must be able to demonstrate comprehension of written English by successfully completing unassisted written tests, including, but not limited to, Work Instructions and Standard Operating Procedures.
Must be able to give and welcome constructive feedback; contribute to building a positive team spirit.
Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.