Quality Assurance Document Control Specialist - Artech LLC
Bothell, WA 98021
About the Job
QUALITY ASSURANCE DOCUMENT CONTROL SPECIALIST
BOTHELL, WA
The pay for this position ranges from $47 to $51 per hour.
BOTHELL, WA
The pay for this position ranges from $47 to $51 per hour.
Required Skills:
- Bachelor's degree or equivalent.
- Library Science a plus.
- Minimum of 5 - 8 years of relevant document control records management experience in a cGMP/FDA regulated environment.
- Strong communication and customer service skills.
- Experience with Part 11 adherence regarding scanning of records and electronic archiving.
- Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).
- Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
- Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
- Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
- Possess project management skills.
- Strong knowledge of cGMPs and domestic regulatory requirements
- Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network.
- Document Scanning experience.
- FDA Documentation & Compliance like 21 CFR Part 11/CGMP.
- Ability to manage competing priorities.
- Accuracy and Attention to Detail.
- Schedule: This person may be required to work weekends. The end date for this contract is 31 DEC 2024.
Project Description:
- The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client's Jump site records management.
- Responsibilities include but are not limited to receiving and reconciliation of GMP records, management of scanning, archival and retention of GMP records.
- Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed.
- Assist with managing the Document Center Archive room.
- Thorough Knowledge of Records Management, Scanning and organization functions.
- Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
This 10+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Jacqueline: jacqueline@alphaconsulting.com
ALPHA'S REQUIREMENT #24-00254
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
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Source : Artech LLC