Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Associate Specialist - Document Control for our client in Bothell, WA. 
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:

• The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for Client 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.

 
Pay Rate: 51.70 $/Hour
 
Responsibilities:

• 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

 
Required Skills:

• Library Science
• MS Office including Word, Adobe, Visio.
• Document Scanning experience
• FDA Documentation & Compliance like 21 CFR Part 11/CGMP
• Ability to manage competing priorities
• Accuracy and Attention to Detail

 
Qualifications:

• Education: 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

 
If hired, you will enjoy the following Eclaro Benefits:

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro

 
If interested, you may contact:
Larah Beaniza

Larah.Robledo@eclaro.com

(332) 209-4549
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

About the Company:
Eclaro

Eclaro is a Business and Technology Consulting Firm that connects top talent with opportunities nationwide. We have direct access to Hiring Managers from leading Fortune 1000 organizations in almost every industry segment, with particular expertise in:

• Technology and Business Consulting
• Financial Services and Insurance
• Pharmaceuticals and Life Sciences
• Consumer Products, Public Sector, and Utilities

Eclaro provides fully customizable, comprehensive talent acquisition and management of seasoned professionals through a number of business models, including:

• Consulting
• Professional Hiring
• Global Integrated Delivery™
• Managed Services

Eclaro recruits and manages a staff of highly skilled individuals in an array of specialized disciplines enabling our clients to leverage new opportunities, respond to increased and changing demands, and increase their profitability.

Eclaro’s Management Team averages over 25 years of experience in partnering with clients in technical, corporate operations and human capital solutions. We hold ISO 9001:2008 certification and have achieved SOC 2 Type 2 certification in Security, Availability and Confidentiality. Eclaro’s decades of expertise and collaborative practice have proven that The Right People are The Answer.

Company Size:
500 to 999 employees

Industry:
Staffing/Employment Agencies

Founded:
1999

Website:
http://www.eclaroit.com