1 Quality - QA Associate - Wednesday-Saturday - 11:00pm-7:30am Job in Bothell, WA

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Quality - QA Associate - Wednesday-Saturday - 11:00pm-7:30am

On Board Companies

Bothell, WA | Full Time

$81k-100k (estimate)

4 Weeks Ago

Quality - QA Associate - Wednesday-Saturday - 11:00pm-7:30am

On Board Companies Bothell, WA

$81k-100k (estimate)

Full Time 4 Weeks Ago

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On Board Companies is Hiring a Quality - QA Associate - Wednesday-Saturday - 11:00pm-7:30am Near Bothell, WA

On-Board Scientific is hiring a Quality - QA Associate Specialist of Bothell, WA! (Shift: Wednesday-Saturday 11:00pm-7:30am)For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position, Title, and State you are located.About Us:On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.Position Details:Position Type: Full Time/ 1 year with a possibility of extension
Job Location: Bothell, WA - Wednesday-Saturday Shift: 11:00pm-7:30am)
Benefits: 401K, Medical, Dental, Vision, and Life Insurance
Compensation: $40.40-$43.55 per hour.
Top Skills:

1-3 years of GMP experience (QC, QA, or MFG)
1-3 years Batch Record Review Experience
1-3 years working in cleanrooms or other controlled spaces.
As a plus experience in quality systems such as deviations, CAPA, Change Control etc.

The Quality Associate II position plays a key role in supporting the cGMP quality operations based in Bothell. Responsibilities include the review of cGMP Controlled Documents such as SOPs, Forms, completed batch records, and conducts walkthroughs of on the floor activities to ensure product and processes meet cGMP and internal standards. This role directly supports the facility release for infusion (RFI) timeline from the date of manufacture and will support all activities for routine clinical and commercial product release with an emphasis on supporting Manufacturing with a Quality perspective within a regulated cGMP environment.

The primary focus of the QA Associate role will be to support routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture at Jump by ensuring documentation is complete, accurate and that Batch records are executed in accordance with approved and effective standard operating procedures and specifications.

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.
Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
Conduct Quality on the Floor activities including quality walk-throughs of the production, testing and warehouse locations.
Execute Quality operations in support of Manufacturing and logistics.
Provide Quality support to Manufacturing personnel on the floor; provide guidance during GMP events and initiation of deviation investigations. 
Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
Oversee manufacturing operations during patient material receipt and drug product pack out.
May participate in revisions of Standard operating Procedures as needed.

Qualifications:

Bachelor’s degree in relevant science or engineering discipline is preferred. A minimum of Associates degree and/or equivalent combination of education and experience is required.
2-3 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing are preferred.
Hands-on experience with batch record review and product disposition is preferred.
Strong computer skills with Word and Excel and other electronic manufacturing systems.
Detail oriented team player with effective planning, organization, time management and execution skills.
Proven experience working on teams where combined contribution, collaboration, and results were expected.
Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
Ability to work in a high paced team environment.
Strong written and verbal skills.

Apply Today!www.onboardusa.com
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability, or genetics.
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