Position Summary:

Responsible for scanning records and verifying accuracy and completeness of scans. Issue QC data packets for test. Archives records and prepares records for offsite storage. Processes document workflows, reviewing documents for correct format and compliance with company templates.

Essential Functions:

• Scans records and verifies accuracy and completeness of scans.

• Prepares records for offsite storage, creating accurate document indexes and ensuring record integrity is maintained.

• Ensures the correct and timely implementation of document requests in editing of controlled documentation. Verifies own work.

• Performs general word processing support and assists personnel in resolving document format issues.

• Processes document workflows to ensure priority documents are promptly processed to meet timelines.

• Maintains, verifies, and ensures correct and complete database and logbook entries.

• Assists with maintaining systems to ensure integrity and security of all documents containing data relevant to product quality and/or quality systems processes.

• Maintains master documents and records (both hardcopy and electronic) as required by applicable regulations such that required documentation is retrievable and files are accurate, complete and well organized.

• Maintains and performs audit of control binders to ensure that adequate and accurate distribution has occurred. Implements corrective actions if discrepancies are found.

• Applies company policies and procedures to resolve a variety of routine issues. Exercises judgment within defined procedures and practices to determine appropriate action.

• Keeps abreast of the basic requirements for compliance in own area of work. Participates as required in training on regulatory issues affecting own area of work. Notifies manager of regulatory compliance questions and issues.

• Follows Environmental, Health and Safety (EH&S) policies and procedures. Takes responsibility for safety in immediate work area. Notifies manager of all observed hazardous conditions or unsafe work practices.

• Performs other related duties and assignments as required and defined by management.

Physical Requirements:

•Document storage and retrieval may require lifting boxes of documents, carrying documents from one place to another and storing boxes on shelves or in file cabinets.

•Handling documents requires repetitive motion using a variety of scanning and computer equipment.

•Should have good keyboarding skills and manual dexterity.

Skills:

Preferred Experience:

• Two years of document control experience in the pharmaceutical/biotech industry.

• Works under general supervision; showing a general level of independence.

Preferred Additional Skills:

• General knowledge of understanding of Document Control standards, practices, and principles.

• General knowledge of understanding of Quality Systems and applicable GMP regulations and standards.

• Demonstrates ability to perform detail-oriented work with a high degree of accuracy.

• Effective written and oral communication skills.

• Effective time management and interpersonal skills.

• Possesses initiative and is proactive.

• Experience with databases and is proficient with the Microsoft suite (i.e. Word, Excel, Visio, PowerPoint, etc.) and Adobe.

• Excellent organizational and planning skills.

• Must work effectively within teams with rapidly changing priorities.

• Builds productive internal and external working relationships.

• Demonstrates good coping skills and analytical problem solving skills.

Education:

• Required: Completed High School (Diploma or GED)