Quality Assurance (QA) Document Control Specialist II

Collins Consulting, Inc

Worcester, MA

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JOB DETAILS

JOB TYPE

Full-time

LOCATION

Worcester, MA

POSTED

30+ days ago

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 What are the top 3-5 skills requirements should this person have? Document Review, doc control extremely proficient in Word Attention to detail What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? Bachelors degree referred Team player, ability to work independently most of the time

About the Company

Collins Consulting, Inc

Collins Consulting brings over two decades of total talent solutions experience to meet your on-demand consulting needs. We have an established history of serving clients nationwide in both the public and private industries. These clients range from Fortune 100 companies within the commercial arena to supporting contracts within federal agencies.

Collins Consulting is a certified Service-Disabled Veteran Owned Small Business and a SBA Small Business. We believe in servicing our country's veterans by supporting and nurturing opportunities to join their skillsets with clients who have the same principles. These certifications coupled with Top Secret facility clearance allow us to meet category and diversity goals.

Collins Consulting is agile, innovative, and an award winning advocate in providing total talent solutions to serve your business needs. Whether you are a professional who is looking for a new career or an organization in need of experienced talent, we have the resources to help you.

COMPANY SIZE

10 to 19 employees

INDUSTRY

Staffing/Employment Agencies

WEBSITE

http://www.colcon.com