Cell Therapy Document Control Specialist
BMS ID # 57803-1 and 57804-1
Seattle, WA or Summit, NJ - ON SITE
12 month W2 contract (with potential to extend or transition to perm)
Pay rate: $27-31/hour - Depending on Education and Experience

Summary:
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the BMS Cell Therapy Above-site organization, including the document approvals, document change control process, periodic review and system reporting.

Position Reports to Jenna Walker – Associate Director, QA Training & Document Control

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

Skills or Requirements:

• 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.

Education/Experience:

• Bachelor's degree or equivalent
• Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment.

What's In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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