Quality

QA Associate Specialist - Document Control

Job Number: (phone number removed)

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 Seattle, 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 the Client Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting.

Pay Rate: 38.15 - 40.46 $/Hour

Responsibilities:

Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state.

May write and revise document control procedures including participating in the development and roll-out of document control tools.

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.

Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures.

Execute the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site.

Generate document management system reports for Quality Council metric reporting.

Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections.

Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.

Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles

Required Skills:

2+ years of Document Control & Reporting Experience,

Veeva experience preferred

Technical troubleshooting

Self motivated, independent, great communication

Experience working cross-functionally

Qualifications:

Education: Bachelor's degree or equivalent

Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.

Strong communication and customer service skills.

Some technical writing skill set including the ability to critically review documents while effectively inputting and expressing Quality principles.

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.

Experience interacting with FDA or other regulatory agencies strongly preferred.

Strong knowledge of cGMPs and domestic regulatory requirements.

Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).

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:

Chris Imbien

(phone number removed)

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.