Document Control Records Management - Specialist - (Entry Level)

Documentation Coordinator I

Top skills: 3-4 years experience - experience using Magic and Veeva would be great

Top three skills: Document control experience, very experienced in Word and Excel, self-driven (accustomed to creating a schedule and hitting it)

Note: candidate will be taking existing documents and putting them into a new format, changing the document control numbers to a new format and uploading them into Magic and/or Veeva (our document control management systems) Develops, produces, and maintains a variety of complex technical and user documentation. Plans and executes writing projects that need attention to complex technical content. Provides effective and useful presentation of that content, and timely reporting of progress in meeting schedule milestones. Complex knowledge and utilization of one or more word processing tools.

Job qualifications: Ability to determine project requirements, perform complex writing, copy editing, technical editing and documentation design activities. Ability to create document structure and graphics at project level. Must have good writing skills. The ability to write consistent and clear documentation with the goal of explaining complex information simply and accurately.

Education and experience: Bachelor's degree and 3-5 years experience or equivalent The Documentation Coordinator I is responsible for the control of Quality Management System (QMS) and quality specific GMP critical documentation.

Key responsibilities include: Ensuring that document reviews and approvals are managed in an efficient and effective manner. Ensuring that all records of document status, outstanding change controls, document reviews, and document approvals are meticulously maintained. Ensuring that documents comply with established templates, formats, and identification naming numbering standards. Ensuring that document cross-references are accurate and traceable. Maintaining the electronic document library and developing and or maintaining a QMS document inventory that includes relevant information regarding document identification, status, effective dating and other pertinent document control information, as required. Managing and controlling specific quality records, as required. Distributing and removing controlled documentation to from points of use, as required.

Qualifications: 1. Bachelor's degree OR a high school education and a minimum of 3 years experience in a GMP controlled environment. 2. Experience using document control strategies or methods in a GMP controlled environment. 3. Knowledge of MS Office products as well as the ability to learn new systems as required. 4. Ability to communicate using English. 5. Prior experience using word processing, spreadsheet, and presentation software.

Essential functions (responsibilities): Distributing controlled documents (procedures, specs) to the Production floor and other points of use. Sorting, filing, and maintaining controlled documents and other Quality Records (e.g. TRVs, DHRs) in Document Control room. When necessary, coordinate off-site storage activities. Process requests for copies of controlled documents and Quality Records.

Qualifications/requirements (basic qualifications): Must have a high school diploma and previous experience with filing. Must be able to lift up to 30lbs and perform physical labor (moving boxes containing documents, bending over to file documents). Basic knowledge of Microsoft Word and Excel. Associates degree OR a high school diploma and a minimum of 2 years' experience in a document control/administrative role. Self-starter with the ability to learn quickly and require minimal supervision. Attention to detail, great organizational skills. Individual who is energizing, passionate, and results/customer oriented.

Excellent communication skills: interpersonal, oral and written. Ability to work in a fast-paced environment, meet simultaneous deadlines, and remain flexible. Ability to work on cross-functional teams and with various departments.