2,076 Records Management Roles jobs in the United States

Precision Edge Surgical Products Company LLC

As a part of the global industrial organization Marmon Holdings-which is backed by Berkshire Hathaway-you'll be doing things that matter, leading at every level, and winning a better way. We're committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone's empowered to be their best.

Review and approval of documents prior to use, including managing the Document Change Request process (ensuring accuracy of document content, revision levels are accurate, and documents are available at each point of use)

Document Control Clerk: As a document control clerk, you will use your exceptional eye for detail to review paper documents for accuracy, scan them into our system, link them to the appropriate customer order, and store them securely. You'll insure compliance for our quality management system with document creation, revision and obsoleting and route those items for electronic approval and signature using Adobe Sign. You'll exercise your written communication skills with MS Word for document creation and formatting.

The ideal candidate will have the following responsibilities:

• Understands and can explain ISO 13485 and the FDA 21 CFR Part 820 and how they drive our document system
• Reviews QMS records for accuracy and exercises good documentation practices; including compliance to ISO 13485 and FDA 21 CFR Part 820, as well as internal procedures
• Scans records and audits the file location and legibility of scanned QMS records, and links files to Global Shop (ERP System)
• Conducts a complete review of shipping documentation prior to shipment release to the customer
• Reviews and routes QMS documentation for approval prior to issue
• Maintains the accuracy of documents at points of use, specifically verifying the most recent version is displayed
• Prevents the unintended use of obsolete documents, and applies suitable identification to them if they are retained for any purpose

• Strong written and verbal communication, prioritization and organizational skills
• Ability to lift 50 pounds
• Stamina to sit for prolonged periods of time working on a computer
• Excellent writing and proof reading skills
• A keen interest and ability to work on complex assignments in collaboration with various department system owners
• Analytical problem solving skills
• Strong team skills and ability to work with others in a positive and collaborative manner
• A demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities
• Basic to intermediate experience with MS Word, Excel, Access and Adobe Acrobat
• The ability to work well under minimal supervision
• Flexibility to adapt to changes in priorities with little notice

• Benefits starting on DAY 1:
  • Health, dental, & vision insurance for employees, spouses and dependent children up to age 26
  • Company-paid short and long term disability coverage
  • Company-paid life and AD&D insurance
  • Voluntary life insurance for employee, spouse and dependent children up to age 18
  • Vacation pay that accrues on a bi-weekly basis
  • Paid Holidays

• Benefits starting on the first of the month following 30 days of employment:
  • 401k retirement savings plan with a 50% company match up to a 3% match

Supporting the dissemination and retrieval of procedures and records throughout the organization for record retention purposes. This includes scanning, logging and boxing documents for off-site storage/retrieval.

• Data Entry
• Project management
• Mail-room coordination
• Prescribing documents
• Report processing
• Customer Service
• Accounting / Billing / Collections

• 2+ years of administrative experience
• Intermediate knowledge using MS Office Applications
• Great written and communication abilities (Assessments may be administered)
• Strong time management skills / organized
• Willingness to work across different departments to ensure production is completed on time
• Experience in the Healthcare Industry field - A plus!

• • Paid Time Off (PTO)
  • Holiday Pay
  • Medical, vision and dental insurance (partial employee contribution required)
  • Voluntary supplemental insurance (partial employee contribution required)
  • Retirement plan (partial employee contribution required)
  • Short and long-term disability insurance
  • Workers' compensation insurance
  • 50k life insurance for employees
  • Kaiser Gold Plan
  • Dental PPO
  • Vision
  • Profit Sharing
  • 401K Matching dollar for dollar up to 3%

Location: 100% onsite

Duration: 5 months with possible extension or FTE conversion

Job Description:

We are seeking a meticulous and detail-oriented Document Control Assistant to join our team. The ideal candidate will be responsible for retrieving, downloading, and organizing sensitive data from various systems, ensuring accuracy and confidentiality. This role requires a high level of attention to detail and the ability to work with large data sets efficiently.

Key Responsibilities:

• Access and retrieve data from multiple systems, ensuring compliance with data security protocols.

• Download and save data into designated folders, maintaining organized and accessible records.

• Handle sensitive information with the utmost confidentiality and integrity.

• Perform data entry and management tasks with precision and accuracy.

• Collaborate with team members to ensure data consistency and reliability.

• Utilize IBM Content Navigator Filenet for document management tasks.

Qualifications:

• Previous experience in document management is preferred.

• Familiarity with IBM Content Navigator Filenet is a plus.

• Strong attention to detail and ability to maintain focus during extended work periods.

• Proficiency in handling large data sets and performing data analysis.

• Excellent organizational and time management skills.

• Ability to work independently with minimal oversite.

• Strong general computer skills.

Overview : An energy renewable client is seeking a highly skilled Document Control Lead to support a growing energy/construction program. The ideal candidate will have a strong foundation in document control and experience managing engineering and vendor deliverables across platforms like SharePoint, Google Drive, and Procore.

Must Haves:

• 8-10+ years of document management experience including expertise with transmittals, submittals, version control, access control, naming conventions, storage/retrieval, audit, reporting, and compliance/governance.
• Experience in Management/Lead role
• Strong Process Development: Build and manage document workflows, revise documents for migration readiness, and implement structured document lifecycle practices.
• Background in engineering, construction, or energy sectors with expertise in engineering and vendor data, including RFIs, drawing validation, etc
• Experience working in SharePoint environments.

Nice to Haves:

• Experience with Procore —both as a user (uploading) and host (managing access and capabilities).
• Experience with Power BI and Power Automate for reporting and workflow automation.

• Prepare Document Change Orders (DCO) using the company's electronic system.
• Review and ensure completeness of records and manage filing (both physical and electronic).
• Manage and update training records, training plans, and database entries.
• Review Device History Records (DHR) for compliance with manufacturing and inspection procedures, equipment settings, calibration requirements, material usage, inspection results, and good documentation practices.
• Assist the Quality Assurance Specialist with equipment calibration and preventive maintenance, including collecting equipment, making database entries, and sending email notifications.
• Scan and file paper records both electronically and in physical file cabinets.

• Proficient in Microsoft Office Suite (Word/Excel) and Adobe Acrobat (PDF editing).
• Experience with SolidWorks is preferred.
• Strong communication and interpersonal skills.
• Ability to thrive in a fast-paced environment.

• AA degree preferred.
• Minimum of 2 years of relevant experience in document control or a related field.
• Previous experience in the medical device industry is preferred.

• Health Insurance
• Health Savings Account
• Dental Insurance
• Vision Insurance
• Flexible Spending Accounts
• Life Insurance
• Retirement Plan

• Provide support and direction to all departments in respect of document control to ensure business, quality and compliance goals are met
• Partners with other Departments to ensure that documentation programs are completed in an efficient manner
• Perform tasks related to tasks related to the management of document control and records management in respect of SOPs and other GMP regulated documents
• Receive and log documents submitted by site personnel for inclusion into the document control system
• Review received documents for conformance to site systems in respect of format, numbering, etc.
• Liaise with document owners in respect of approval schedules and implementation of new or revised documents
• Provide feedback from document review to the document owners

• Add new users to the system and assign privileges as directed by the QA Systems Manager
• Set up review and approval routings for SOPs and other GMP regulated documents as directed by the QA Systems Manager
• Track documents through the review and approval processes and advise relevant personnel accordingly.
• Participate in upgrading activities of the system as appropriate.
• Generate reports from the system as directed by the Quality Systems Manager

• Develop and apply systems and procedures related to the Electronic Document management System at the site
• Perform tasks related to the storage and archiving of documents related to BioNC including validation documents
• Prepares and catalogues documents for archival
• Coordinates with internal and external groups for the archival of documents
• Manages document retrieval from archive storage as requested.
• Regulates access to on-site document storage
• Audits internal and external document storage/archive systems

• Partner with BioNC Learning & Development department in the provision of training in Good Documentation Practice (GDocP) and GMP to site personnel as directed by the Quality Systems Manager
• Assist BioNC Learning & Development department the development and maintenance of training materials for provision of GDocP and GMP training to site personnel
• Coordinate periodic review of all GMP documentation with site personnel
• Manage the record retention program as it applies to global and local requirements
• Support in inspection readiness at the as documentation and records management SME
• Serve as a delegate for Quality Systems Manager, when appropriate
• Perform related duties as assigned by supervisor
• Maintain compliance with all company policies and procedures

• Bachelor's degree in a scientific, engineering, or technical discipline is required
• minimum of 3 years of experience in document management or related role within the biological and/or pharmaceutical industry
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals and ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position
• Excellent computer proficiency electronic document management system (i.e. Veeva, Master Control, Documentum, etc.)
• Excellent communication and interpersonal skills with the ability to effectively collaborate with cross-functional teams
• Proven ability to manage multiple priorities and work independently with minimal supervision
• Detail-oriented mindset with a keen eye for identifying opportunities for process improvements
• Ability to work in a team environment and interact with all levels of the organization
• Ability to build and nurture strong and positive relationships
• An unquestionable level of integrity and commitment to operate ethically and within the boundaries of regulatory requirements
• Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.

• Documentation management and systems experience
• Computer proficiency
• Knowledge of FDA regulatory requirements for Biologics

• Process completed production into the inventory control system in a timely manner.
  
• Generate and manage production reporting for applicable shifts.
  
• Assist with preparation, printing, and application of carton and pallet labels.
  
• Safely handle, identify, transport, and store incoming raw materials, colorants, product containers, and related items.
  
• Assist with organizing and maintaining inventory across storage racks and warehouse areas.
  

• Serve as a backup to the Quality Assurance Inspector (QAI) as needed.
  
• Provide relief break coverage for quality staff.
  

• Assist in relief breaks for fellow inventory team members.
  
• Label and wrap shipping containers; verify pulled orders.
  
• Keep work area clean and product organized.
  
• Perform other duties as assigned by management.
  

• High school diploma or equivalent required.
  
• Minimum 2 years’ experience in inventory control preferred but not required.
  
• Ability to safely operate forklifts/jitneys (stand-up and sit-down) and powered tow trucks.
  
• Familiarity with packaging tools and equipment (hand-held scanners, scales, tape dispensers, barcode printers, shrink wrap/banding machines).
  
• Basic computer skills, including Microsoft Outlook and Word.
  
• Strong math skills (addition, subtraction, multiplication, division, fractions, decimals).
  
• Basic knowledge of inventory control methods, ISO standards, and quality processes.
  
• Professional and team-oriented attitude.
  
• Regular standing, walking, and reaching with hands/arms.
  
• Ability to climb, balance, stoop, kneel, crouch, or crawl as needed.
  
• Must be able to lift and move packages up to 100 lbs.
  
• Frequent use of hands for handling, scanning, and labeling.
  

• Full Time
  
• Second shift (3pm - 11pm)
  
• $15.00/hr
  
• Temp to hire position
  
• Weekly pay while employed through Career Concepts
  
• Benefits available while employed through Career Concepts
  

• Erie, PA 16502