Job Description

QA Associate Records Coordinator
Job Number: 21-14807
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA Associate Records Coordinator 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;
  • Perform scanning, compilation and archival of GMP documents/records related to Manufacturing Operations ensuring original records security, facilitate data integrity, ensure easy/timely retrieval of records, and support internal and regulatory inspections.

Responsibilities:
  • Maintain the GMP Document Center Archive room.
  • Ensures all paper GMP documents/records/labels are scanned, organized, labeled, and stored in the appropriate location in a manner that enables quick and easy retrieval.
  • Assists with inventory management
  • Participates in the development and deployment of site archival programs and initiatives.
  • Organizes and associates related paper documents/records (e.g., Lot Disposition File) into a single package or file system.
  • Ensures packages are complete with all attachments based on identified list of contents. If gaps are identified, work with team members to identify missing elements.
  • Compile and scan paper batch records and other controlled GMP documentation to a secure file share
  • Using the existing document tracking tools, ensure accuracy and traceability for all documents stored in the GMP document archive room.
  • Follow and enforce room policies and procedures as set by Document Control
  • Follow Policies, SOPs and work instructions to support the GMP Records Management process
  • Support internal and external audits and regulatory inspections.
  • This may require scanning, and document retrieval /organization during regulatory inspections

Required Skills:
  • Must be able to demonstrate extremely efficient and effective organization skills with extra attention to details
  • Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables
  • Able to successfully manage multiple priorities
  • 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)
  • Teamwork and the ability to interact well with others are essential.
  • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)
  • Must be able to self-direct, multi-task, and clearly communicate to the manager of decisions outside of established processes and the ability to build an internal network.

Qualifications:
  • Previous experience working in a professional office environment
  • Experience in a cGMP/FDA regulated environment preferred
  • Experience in document and database management is highly desirable.
  • Bachelors degree or equivalent

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:
Jane Bautista       
froilyn.bautista@eclaro.com
2012858622
Jane Bautista | LinkedIn
 
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.

Application Instructions

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

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