Quality Assurance Technician

Job Description

Job Title:                     Document Control Clerk
Department:                QA/RA
Reports to:                  Director of QA/RA
FLSA Status:               Non-Exempt
Approved By:              Roxanna Jurgeit
Approved Date:           5/28/26

Summary
Under supervision, the Document Control Clerk assists with creation and maintenance of files, locates materials, assists in the location of data, and related work as required.  This person is responsible for following ISO 13485 and US FDA Title 21 CFR Part 820 QSMR requirements to adhere to record retention policies, safeguard information, retrieve data efficiently, and manage company documents while also ensuring their accuracy, quality and integrity.

Essential Duties and Responsibilities
Duties include, but not limited to the following, as other duties may be assigned.

• Process documents for revision and organize and track the routing of documents throughout the process from DCN submission, approvals, distribution to filing.  Notify managers/supervisors (when changes occur, when training is required).
• Process, distribute, and maintain controlled documentation using a document control system.
• Scan and file company quality records (QSPs, Ops, WIs, forms and completed records, etc.).
• Create files, assemble documents, checks for duplication, maintains sequence, ensure documents are in the correct format and are complete and accurate.
• Receive and process requests for information and maintain the requests via tracking logs or check out cards.
• Assist with Audit and Training activities as needed.
• Inventory Control: verify all materials listed in BOM are on the associated work order; maintain inventory control on distribution sheets for all levels of production routers
• Archive records using controlled process so that records are retrievable.
• Performs a variety of general filing duties of varying difficulty.
• Maintain office supplies for QA department; submit purchase requests to ensure supplies required are available
• Keeps files neat and orderly and repairs files as needed.
• May assist in entering data into computer system, word processing and other duties as required.

Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  Must have the ability to prioritize, manage time well, multitask and troubleshoot.  Document control personnel often work in a fast-paced and deadline driven environment, so it's important they can stay focused and carry out their tasks in a timely and accurate manner. They should be detail-oriented, dependable and trustworthy since they come in contact with complex and sensitive documents.
Education and/or Experience
High school diploma or general education degree (GED); or six to twelve months related experience and/or training; or equivalent combination of education and experience.
Language Skills
Ability to read and comprehend written and verbal instruction, short correspondence and memos.  Strong interpersonal, communication and customer service skills are also essential because document control specialists regularly communicate (verbally and in writing) with internal and external business partners. 
Mathematical Skills
Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. 
Reasoning Ability
Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. 
Other Skills and Abilities
Proficiency in Microsoft Office applications (word, excel, powerpoint, access, outlook, teams, etc.) and experience with MasterControl preferred.