Quality Assurance (QA) Document Control Specialist II

This is a 100% onsite position.

Description Details

General Position Summary / Purpose : Assists in maintaining a compliant, efficient Quality Assurance Document Management program.

Key Accountabilities / Core Job Responsibilities :

Under direct supervision, perform day-to-day Document Control activities : Process DCR packages and review for correctness and completeness; monitor and update in-process documents; create, assign and archive QA controlled lab notebooks and logbooks; assist in managing the electronic document management system; assist in managing access to Master Documents in the Document Control Vault; and create reports. Performs duties in support of established records management procedures, including scanning, filing and managing offsite records storage and retrieval. Participate in internal audits. Assist in updating SOPs. Participate in regulatory inspections. Provide user assistance with using the Electronic Document Management System.

Qualifications :

General knowledge of electronic documentation systems, data retrieval, and electronic file formats. Working knowledge of Quality Systems, GMP-related requirements and ICH guidelines, desirable. Willing to learn new areas of responsibility. Detail oriented with solid problem solving acumen. Ability to work effectively in a team environment. Ability to analyze and reconcile moderately complex issues. Must have demonstrated initiative and accountability in a fast paced environment. Excellent verbal and written communication and interpersonal skills. Proficient with computers and word processing software (i.e. Microsoft Office products).

Years of experience / education and / or certifications required :

• High school diploma with 2 + years of general document control experience.
• 0-2 years of pharmaceutical experience in a GMP environment.
• 0-2 years experience using and administering electronic document management tools

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