Quality

On-Board Services is hiring a

Quality - QA Shop Floor Specialist in Bothell, WA.

For immediate consideration please send your resume to

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: Quality - QA Shop Floor Specialist

Job Location: Bothell, WA

Benefits: 401K, Dental insurance, Life Insurance, Medical Insurance, Vision Insurance

Compensation: $43.32 - $45.94 /hourly (based on experience)

Duration: 6 - month

Schedule: 9:00pm - 7:30am, Sunday - Wednesday

Description:

The Quality Assurance Specialist position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump). Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, specifications, completed batch records, material disposition, and manages implementation of required changes to meet cGMP and internal standards. This role directly supports Jump's release for infusion (RFI) timeline from the date of manufacture and will support all activities for routine clinical and commercial product release at Jump with an emphasis on supporting Manufacturing with a Quality on-the-floor presence within a regulated cGMP environment.

The primary focus of the QA Specialist 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.

The QA Specialist primary role is on-the-floor and contributes with off-the-floor projects and activities that are just as significant as on-the-floor work.

Responsibilities:

• Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.

• Provide Quality on-the-floor oversight including quality walk-throughs of the production, testing and warehouse locations to ensure practices fully adhere to cGMP.

• Provides technical knowledge and guidance towards GMP compliance during triage/troubleshooting activities.

• Review deviations, product non-conformities, and GMP investigations to ensure compliant resolution and adherence to current Good Manufacturing Practices (cGMPs).

• Own, review, and approve deviations, including Deviation classification and completion of Impact Assessments, as applicable.

• Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.

• Oversee manufacturing operations from patient material receipt to drug product pack out.

• May support internal and external audits, including documenting observations.

• Own and participate in review and approval for CAPAs.

• Identify and facilitate continuous improvement projects.

• Revise Standard operating Procedures as needed, and review/approve document revisions.

• Drives right first time (RFT) by providing direct training, guidance, and problem solving to peers.

• Provide training, coaching, and feedback for GMP guidance.

• Continue support of continuous improvement culture and operational excellence methodologies.

• Support change control initiatives as applicable.

Lab w/ Blood and Animal

Qualifications:

- 3-5 years of GMP work experience

- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.

- Familiarity with Batch Records

- Deviations Experience Preferred

- Associates or BA Degree preferred, or HS Diploma + relevant work experience

- Soft skills include- strong cross-functional experience, strong interpersonal skills

- Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, Management Monitoring and Self Inspection auditing, QA reporting, and approval of GMP documentation.

-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.

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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