Document Control Analyst jobs in Durham, NC

Description

About the role:

The Document Control Coordinator ensures the effectiveness of the document management system and training program, in support of FDA 21 CFR Parts 210, 211, 820 and ISO 13485:2016. The Coordinator works with the Management Team to assure compliance to customer requirements, external standards, and internal specifications/procedures.

What you will do:

• Assists in the implementation and maintenance of the Quality Management System (QMS) documentation system and associated processes while ensuring compliance to applicable standards, regulatory and customer requirements and overall protection of company intellectual property.
• Assures the Document Change Control Request process is performing as stated in the applicable Work Instruction (WI).
• Routes, maintains and revises controlled documents and specifications including Standard Operating Procedures (SOPs), Work Instructions (WIs), and Internal Specifications following established processes to ensure revision control records are maintained.
• Assures control of quality records (including records retention) are compliant to procedure and WIs.
• Conducts new hire Quality Orientation Training.
• Work with Quality Management to ensure that documents are released and become effective after personnel have been trained.
• Assists in internal/external audits and supplying documents as applicable.
• Supplies applicable Metric Data as requested.
• Maintains the Deviation Log and issues deviation numbers.
• Maintains off-site storage of records, including requesting pickups, ordering boxes, etc.
• Performs other activities and other projects as requested by RA/QA Management.
• Acts as a Quality ambassador for the company to promote Quality culture.

Qualifications

Who you are:

• High school graduate or equivalent required. Associates Degree preferred.
• 2 – 3 years of experience in a regulated environment (e.g., ISO 13485:2016, 21 CFR Parts 210, 211 and 820) in one of the following functions: Quality Control/Assurance or Document Control , preferred.
• 1-2 years’ experience developing or maintaining a controlled document system in a regulated industry required.
• Possess excellent communication, organizational and computer skills.
• Must be able to work independently and set priorities in alignment with business needs.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)