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Quality Assurance Document Coordinator
Ref No.: 17-01558
Location: West Lebanon, New Hampshire
Position Type:Contract
Start Date: 11/13/2017
QUALITY ASSURANCE DOCUMENT COORDINATOR
WEST LEBANON, NH

Project Description:
This position is part of the Quality unit and is responsible for supporting document and record controls. Tasks are conducted in a GMP manner, and in compliance with company standard operating procedures and regulatory requirements. The position primarily completes/finalizes the processing of documents within the electronic document management system, and also coordinates and carries out record and data archival activities in accordance with record retention schedules. The position will participate in other projects and duties, as assigned, in support of the management and maintenance of the document and record control process.
  • Process documentation changes using an electronic documentation management system. Work and interact with technical staff or subject matter expert to resolve documentation issues.
  • Maintains all Quality Assurance Documentation files (paper and electronic) in accordance with internal procedures.
  • Supports and carries out required tasks for the following departmental programs: review of external standards, scanning/imaging of records by contracted service provider, logbook and lab notebook control, updating the CCA database.
  • Issue/reconcile Quality controlled documents such as: batch records, formulation tickets, log/lab notebooks, and intermediate product labels.
  • Report status of outstanding batch records, formulation tickets, logbooks, etc. to Functional Area Managers as assigned.
  • Participate and/or support training on Documentation Quality Documentation Systems to Client employees.
  • Create/revise existing departmental SOPs, work instructions, training guides and checklists as necessary.
  • Physical requirements may include lifting up to 25 lbs., long periods of standing and negotiation of stairs.
  • Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.
  • Incorporates the Client Way in all activities and interactions with others.
  • Incorporates the Client Way and 10 Essentials in all activities and interactions with others.

Required Skills:
  • High School diploma (or equivalent) and a minimum of three (3) plus years related experience in document management, word processing, data entry, QA or related field, preferably in a GMP or ISO environment.
  • An Associate's degree (or equivalent) and 0 plus years' experience in document management, word processing, data entry, QA, or related field, preferably in a GMP or ISO environment.
  • Must have strong skills in organization, record keeping and communication.
  • Excellent writing, grammar and proofreading skills are required as well.
  • Exceptional attention to detail is essential.
  • Strong oral and written communication skills and outstanding customer service skills are required since this position will interact with individuals at all levels of the company as well as individuals outside the organization.
  • Command of software programs; specifically Microsoft Word, and competent in use of Microsoft Excel, MS Access, MS Visio, and MS PowerPoint is required.
  • Knowledge in electronic quality management system software such as Trackwise or SmartSolve, or other electronic document management systems is desired.
  • Ability to use other document software programs (AutoCAD, Adobe Professional, etc.).
  • Must be able to work in a team environment, demonstrating ability to take direction, participate, take lead and work with a variety of people.


This 5+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Ashley: ashley@alphaconsulting.com

ALPHA'S REQUIREMENT #17-01558
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE