Document control coordinator job description

At HealthFirst, we provide solutions that integrate technology, products and services with the latest regulatory knowledge, enabling healthcare providers worldwide to effectively meet their evolving compliance obligations. HealthFirst's success is driven by our team of uniquely capable people whose similarities and differences make us who we are. We are committed to providing excellent customer service experiences and compliance peace of mind.

HealthFirst is seeking a Document Control Coordinator in their QA department to join the team. This role will be responsible for processing, maintaining, and record management of the company's GMP document control system while also ensuring the accuracy, quality, and integrity of the content. This individual will ensure company adherence to required training's and will be responsible for the maintenance of all controlled documentation within the electronic document control system among other duties and responsibilities. This is an excellent opportunity for an individual who is looking to advance in a Quality Assurance role.
Primary Job Responsibilities:


Act as an admin for the document management software. Assist with document migration and organization from the existing document management system to the new document management system. Execute document approval, release, archival, and obsolescence, per the Quality System. Assist with reviews and edits to SOPs as needed. Review documents per Good Documentation Practices compliance. Provide document support for internal and external audits, as needed. Manage changes to the quality system documents and work with SMEs and process owners for collaborations. May lead and provide training associated with the understanding and management of Quality System. Responsible for the routine maintenance of active and archived controlled documents and records in accordance with department SOPs. Responsible for checking the "Document control mailbox for Change Requests and other related requests daily. Manage and maintain off-site storage, document retention and retrieval of documents per department SOP. Support any training needs regarding the quality system documents in collaboration with HF's learning and development system. Perform Document Control metric reporting and analysis for the local site data. This position assumes and performs other duties as assigned.



Requirements:


A minimum of 3 years of Quality Management System, Document Control, and Records Management in a biotech, Medical Device, or pharmaceutical industry. Strong understanding of QMS, and Good Documentations Practices per 21 CFR requirements. Experience with multiple document management and eQMS systems preferred. Proficiency in Windows applications, (Word, Excel, and PowerPoint). Experience working in Smartsheet desired Strong Communication Skills (written and verbal). Self-motivated, flexible & creative, able to prioritize, multi-task and work in a fast-paced & demanding environment. Must be able to work independently with minimal supervision and in a team-oriented environment. High attention to detail


HealthFirst thanks our dedicated team members by offering a competitive base salary and incentive plan, a comprehensive benefits package that includes medical, dental, vision, disability, life insurance, 401k, tuition reimbursement, 20 days of PTO to start, and much more!

HealthFirst is an equal opportunity employer and does not discriminate against applicants or employees based on race, color, religion, creed, national origin, ancestry, a disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Maintain company's technical document library in compliance with company directives. This involves working closely with quality, engineering and business development functions to ensure accurate and retrievable documents are on file. The Document Control Coordinator is an individual contributor that enables the business to be compliant with customer, FAA and corporate requirements for accurate, current and authorized data.
JOB RESPONSIBILITIES:
Administers the collection, publication, storage and retrieval of paper and electronic documents. Administers the document lifecycle (author, approve, publish, revise, retire, archive) for company documents, including drawings, procedures, and forms. Prepares electronic document templates. Scans documents, update procedures, and create documents as required. Maintains the master document database. Manage document processes and systems to ensure control and availability of documentation to site personnel. Performs and/or support regular audits of document control processes and procedures. Maintains SharePoint project lists and libraries, and assist in SharePoint development and user training. Acts as Administrator for various Customer websites to give permissions to access.
Take your career higher at Textron Aviation.
•Competitive starting salaries with growth potential
•Health benefits beginning day one
•Tuition assistance and continuing education programs
•12-paid holidays a year
•Paid parental leave options
A new career awaits.


EDUCATION:


High School diploma, WorkKeys, or equivalent.


EXPERIENCE:


Preferred experience with document control and administration or equivalent experience.


QUALIFICATIONS:
Computer skills and ability to navigate software systems Excellent attention to detail. Ability to request quotes for documents and services, and to compare and evaluate quotes and make recommendations for purchase. Basic operational understanding of the relevant technical documents used to perform aircraft maintenance. Ability to apply this knowledge in the ordering, storage and retrieval of technical documents. Ability to work to deadlines and ensure the documents are accurate, effective and complete. Capable of effectively communicating with and influencing different levels of the organization - mechanics, IT, Able management and Textron resources. Good customer service skills when communicating with mechanics, leads and engineers around document requirements and deadlines. Ability to thrive in a team environment that requires peer reviews and cross-functional sharing of info.

Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

Under minimal supervision, maintains Device Master Record and Device History Records as part of the quality system, and maintains department databases. Reviews batch records and performs product release activities.
Principal Duties and Responsibilities

* Creation of Device Master Records such as routers, master cross references, and bill of materials within the ERP system.
* Maintain Master Batch Records, Device Master Records and Device History Records as well as other quality system documents such as training records, monitoring records, authorized signature lists, etc.
* Assist with new part number assignment process by creating new part numbers within ERP system for design teams and Marketing department.
* Assist with leading weekly change control meetings and processing of all change orders within the quality system.
* Handle distribution of all change orders (engineering, specification, and labeling) to appropriate departments.
* Assist with the maintenance of the company intranet, Livelink/SAP web-based software to ensure the most current document revisions are available at all points of use.
* Assist with processing Instructions for Use and all labeling intended for domestic and international distribution. This includes approval of product labeling using the label producer software.
* Review Master Batch Records, Device History Records and perform product release activities.
* Maintenance of various databases to ensure compliance to regulations such as indices used for procedures, drawings etc.
* Assist with preparing and organizing documents for offsite storage archival and/or archival onto CD. Maintain storage logs.
* Process and distribute various document requests to departments as needed.
* Complete various projects as assigned by the supervisor in addition to general filing and copying.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Expected Areas of Competence

* Ability to objectively deal with individuals using appropriate tact and diplomacy to establish and maintain a congenial relationship.
* Good verbal and written communication skills.
* Good word processing and database skills.
* Outstanding organizational skills and high attention to detail.
* Knowledge of current Food and Drug Administration (FDA) laws, regulations and practices a plus.