Document Control Specialist na EPTAM Precision Molding
EPTAM Precision Molding · Lancaster, Estados Unidos Da América · Onsite
- Professional
- Escritório em Lancaster
EPTAM Precision Molding is looking for a Document Control Specialist to join our team in Lancaster, MA
EPTAM Precision Molding is a trusted injection molding solutions partner. We are dedicated to supporting the complete product lifecycle in consumer products, healthcare, and defense industries. We're committed to helping our customers bring their products to market and streamline their supply chain.
EPTAM Solutions, Our parent company, with locations nationwide, is at the Heart of Manufacturing. We recognize our parts touch lives, and our teams assume this responsibility with vigor. Our minds never sleep. Join our incredible team at any one of our locations and reap the benefits of an employee-focused company. We excel at what we do for our customers, our employees, and the world.
Benefits Include:
- Professional Development/On the Job Training
- Health and Wellness Benefits
- Clean, Friendly, Safe work Environment
- Recognition and Rewards Program
- Tuition Reimbursement
- Competitive Pay/Merit Increases
- 401k w/ Company Match
- Employee Assistance Program (EAP)
SHIFT DETAILS:
1st Shift Monday to Friday 7:00 am - 3:00 pm
POSITION SUMMARY: The Document Control Specialist manages and maintains the documentation that supports the EPTAM Quality Management System (QMS), ensuring it’s accurate, up-to-date, and compliant with regulations. This includes overseeing the lifecycle of controlled documents, coordinating reviews and approvals, and managing document storage and retrieval systems and is primarily responsible for the following:
- Managing and maintaining the company’s document control system, including electronic document management systems (eQMS).
- Ensuring all documents adhere to relevant standards (SIO-13485, FDA 21 CFR Part 820, EU Medical Device Directives Regulations).
- Coordinating and managing the creation and changes, review, approval, distribution, accessibility and archiving of controlled documents.
- Coordinating change control activities with all departments to implement and maintain the document management and control process.
- Ensuring documents are approved and signed by the appropriate parties and that all data is stored and backed up, as required.
ESSENTIAL FUNCTIONS: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Review document changes for correctness, proper headings, pagination, numbering flow, etc. as well as adherence to Document Control procedures.
- Review document changes for adherence to Document Control procedures.
- Distributing updated documents to production areas as well as suppliers.
- Fulfilling Document Retrieval Requests.
- Manages numbering to be utilized on documents and records’ templates.
- Manages changes to documents and ensures proper documentation of those changes.
- Have a thorough understanding of the filing system to be able to retrieve documents and data quickly and effectively as required.
- Organizing and archiving documents involving scanning, copying, physically and /or electronically filing.
- Provide training and support for staff on document control procedures and systems as appropriate, associated with changed documents or processes.
- Facilitate MRB functions including collating and recording NCMR data from the NCMR forms and logs to an electronic format for analysis, following up on required investigations, and ensuring records from the process are organized and stored appropriately.
- Maintain quality records, such as Device Master Records (DMR, Device History/Batch History Records).
- Employees must be able to relate to other people beyond giving and receiving instruction. Can get along with co-workers or peers and respond appropriately to feedback from a supervisor in a professional manner.
OTHER RESPONSIBILITIES:
- Good housekeeping, safe working habits, and conducting self in a professional manner.
- Collaborate with various departments, including Engineering, and Operations/Production, to ensure document accuracy and completeness.
- Proper handling and transportation of all materials, parts, and equipment to prevent damage and loss of finished product.
- Represent the company as required during customer, internal and ISO audits, as well as FDA inspections.
- Understand the sensitivity of the data handled by the systems under your control and take appropriate measures to protect it.
MINIMUM JOB QUALIFICATIONS REQUIRED:
- EDUCATION: High school diploma or general education degree (GED).
- EXPERIENCE: 2+ years of QA/QC experience with some focus on related administrative duties, preferably in a manufacturing environment, equivalent combinations of education and experience accepted OR demonstrated ability to execute the Essential Functions for this position. Internships and PT experience acceptable.
- LICENSES, CERTIFICATIONS AND REGISTRATIONS: None
OTHER QUALIFICATIONS AND SKILLS:
- Familiar with FDA, ISO 13485, ISO 9001, or equivalent Quality Management Systems.
- Must possess time, stress, and organizational management skills.
- Organized, attentive to detail and able to prioritize and handle multiple projects with competing deadlines.
- Works efficiently both on an independent basis and part of a team.
- Ability to deal effectively with all levels within the organization, as well as with external parties, including regulatory bodies.
- Proven strong problem-solving ability with attention to root cause.
- Maintains a personal and professional ‘continuous improvement’ philosophy.
- Excellent written and verbal communication skills, legible handwriting that meets GDP requirements, and strong interpersonal skills.
- Excellent skills in Microsoft Office suite: Word, Excel, Outlook, and PowerPoint.
- Proficiency in using and managing electronic document management system (eQMS).
ADP1410
ZZJ-251010-440
SHIFT DETAILS:
1st Shift Monday to Friday 7:00 am - 3:00 pm Candidatar-se agora
