Document Control Associate Job Description
This position provides crucial administrative support to the QA department, facilitating work flow. When administrative demands are low, this person will take on and execute key projects in support of QA Department goals and objectives.
Essential Duties and Responsibilities
Scans labels and cartons for all received lots to make them globally accessible to employees
Performs archive and rotation of files to maximize storage space
Cross-trains with QA personnel to learn the critical daily activities of their job and serve as a back-up when personnel are absent
Assists with document review, approval, and archiving
Processes documents, such as specification sheets
Develops and executes strategic document control projects
Processes receiving paperwork for raw materials daily; reviews, scans, maintains physical files, and maintains electronic files
Processes laboratory test results (completed specification sheets) for raw materials daily; scans and files documents; maintains related electronic spreadsheet
Maintains bottling records after approval of finished products; file records; performs ‘end of lot’ reconciliations and maintains reconciliation log
Scans and archives batch records (55s, 65s), OOS investigations, NMR reports, Master Formulas, and material reviews
Pulls files from QA Central File for long-term storage and maintains a spreadsheet of files and storage locations
Updates Document Control Administrator of any document control issues or obstacles that may impede document processing or other assigned duties.
Informs staff and/or management as appropriate when documents that are to be filed or scanned are filled out incorrectly or are incomplete.
Files and scans documents in a manner that are easily retrievable and in accordance with CFR part 111
Education and/or Experience
High School Diploma or GED required
Al least 2 years of experience working in Quality Control or Quality Assurance preferred
Knowledge, Skills and Abilities
Excellent time management and organization skills
Ability to take initiative
Strong interpersonal skills
Intermediate level skill with Microsoft Office applications (especially WORD and Excel) and the ability to learn and use company software and database programs
Knowledge of FileMaker and Sage is helpful
Strong understanding of document workflow and document storage practices
Ability to read and comprehend simple instructions, short correspondence and memos
Ability to write simple correspondence
Ability to effectively present information in one-on-one and small groups situations to customers, clients and other employees of the organization.
Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
Ability to compute rate, ratio and percent and to draw and interpret graphs.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to stand and walk; sit; use hands to finger, handle, or feel; and reach with hands and arms. The employee is occasionally required to climb or balance; stoop, kneel, crouch, or crawl, talk or hear; grasping, carrying; and taste or smell. Specific vision abilities required by this job include the ability to be able to view a computer screen.
This position will work regularly at a desk and computer, reviewing documents and accessing databases, logs, and scanned records. Frequently, this position will be required to visit the manufacturing area to gather information or explanations from individuals – which will require wearing a lab coat, hair net, and/or beard net (as applicable). Work area may be upstairs and require use of stairs multiple times a day.