Summary
The Document Control Associate is responsible for administering and maintaining ASC's document control system to ensure controlled documents and records are created, reviewed, approved, distributed, revised, archived, and retained in accordance with the Company's Quality Management System and applicable regulatory requirements.
Duties
- Establishing and/or administering a documentation filing system for all policies, procedures, specifications, and/or forms.
- This may include creating, reviewing, collecting, updating, storing, retrieving, securing, controlling revisions and destruction of old records. This is typically done both for physical and electronic documents to ensure that official records are kept secure, up-to-date, and readily retrievable.
- Coordinating the creation, review, revision, approval, and release of Standard Operating Procedures (SOPs), work instructions, specifications, forms, and validation protocols.
- Maintain document revision history and ensure only current approved versions of documents are available for use throughout the organization.
- Developing and utilizing classification systems to enable storage and quick retrieval of information.
- Revising documents as needed and coordinating review and approval of SOPs, specifications, and forms.
- Administering timely and appropriate distribution of documents (Assure updated documents are available and used.)
- Maintain controlled documents within the company's electronic document management system (eDMS/eQMS).
- Ensure document revisions, approvals, and obsolete document archival are completed in accordance with company procedures.
- Support document change requests and Change Orders through the document approval process.
- Track document status to ensure timely review and approval.
- Perform periodic reviews of controlled documents to ensure continued accuracy and compliance.
- Maintain document retention and archival records in accordance with company policies
- Assisting in the training on policies, procedures, and forms for their use.
- Participating in internal and external audits as required.
- Establishing and maintaining best practices in handling of documents.
- Keeping managers informed of situations that may affect documentation.
- Identify document-related training needs and support company-wide compliance.
- Prepare ad-hoc reports on projects as needed.
- Technical Writing: Authoring regulatory documentation including SOPs, product manuals, Instructions for Use (IFUs), process flows and work instructions.
- Review and prepare labeling, training, promotional, and advertising material.
- Assures consistent and standard process exists to perform proactive surveillance (e.g., regulatory database searches, literature reviews).
- Assist with product and facility registrations globally, including requesting certificates.
- Creating Global Trade Identification Numbers (GTIN), updating, and maintaining labeling databases such as Access GUDID and Eudamed.
Skills
- Data driven
- Team Player
- Forward thinker
- Positive mental attitude
- Ability to accurately document information.
- Ability to utilize imaging devices to scan and use computer software to transfer data from physical to electronic records.
- Accuracy and attention to detail, including strong written and verbal communication skills.
- Computer skills, including the ability to learn and use one or more versions of specialized software such as MS Office.
- Ability to develop, implement and enforce policies and procedures.
- Ability to manage multiple priorities.
- Ability to perform detail-oriented work, coordinate multiple projects, perform presentations, and adapt to a flexible environment with changing daily workload and priorities as directed.
- Organizational skills to track open items, persistence in follow-up and solid time management skills.
Education and Experience:
- Associate's or Bachelor's degree in Business, Life Sciences, Engineering, Quality Assurance, or a related field preferred.
- 2–4 years of document control experience in a manufacturing or regulated operations environment, preferably within the medical device industry.
- Experience using electronic Document Management Systems (eDMS/eQMS) preferred.
- Working knowledge of ISO 13485 document control requirements preferred.
- ISO 13485 Internal Auditor certification preferred.
Language Skills:
- Must be fluent in English, with the ability to read, write, and communicate technical information clearly and effectively in both verbal and written formats.
- Proficiency in Spanish is a plus and may be beneficial for effective communication in a diverse manufacturing environment.
Pay: $65,000.00 - $85,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Disability insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
