We are seeking a highly organized and detail-oriented Document Control Coordinator to join our Quality team at Polyzen. This role acts as a quality ambassador for the company by supporting the effectiveness of our document management system to ensure compliance with customer requirements, external standards, and internal specifications.

Who you are:

• High School Graduate or equivalent, required.
• 1-2 years experience maintaining a controlled document system in a regulated industry, required.
• 2-3 years of experience in a regulated environment such as ISO 13485 or FDA in QC/QA or Product Development highly desired.
• Demonstrated proficiency with Microsoft Office and Adobe applications, ComplianceWire, BarTender/labeling software, and the capacity to learn new systems.
• Possess a demonstrated workstyle that is highly organized, methodical, and with attention to detail.
• Ability to organize/prioritize a dynamic workload to complete tasks and on-time.

What you will do:

• Assist 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.
• Assure 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 are compliant to procedure and Wis, Verifies and confirms completion of assigned quality training as applicable.
• Supports onboarding with new hire Quality Orientation Training.
• Work with Quality Management to ensure that documents are released and become effective after personnel have been trained.
• Reviews accuracy of labels in labeling software as the Administrator/Super User.
• Assists in internal/external audits and supplying documents as applicable.
• Maintains the Deviation Log and issues deviation numbers, supplies applicable Metric Data as requested.
• Maintains off-site storage and pickup of records, performs other activities and other projects as requested by RA/QA Management.

Other Duties

• Adheres to Good Manufacturing Practice (GMP)/Quality System Regulation (QSR) requirements and follows applicable QMS documentation such as Standard Operations Procedures (SOPs) and Work instructions to successfully accomplish job requirements.
• Follow Personal Protective Equipment (PPE) and gowning procedures in designated areas.
• Follows established safety requirements and adheres to the Health Safety and Environment Management System.

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)