is one of the premier staffing and recruiting companies in the Pacific Northwest. Launched in 2001, we are a woman-owned business that serves and staffs Northwest organizations by doing things the right way, not just the easiest way. Hansell Tierney partners with candidates and clients to match the best candidates with interesting local opportunities. We navigate every relationship with the highest level of discretion and service while holding ourselves accountable to our promises. Our business thrives on our deep understanding of the job market and our ability to skillfully tailor our recruitment process to meet our clients’ unique needs.
We are currently helping our client, a Seattle-based bio-pharmaceutical company, with a search for a Lab Operations - Quality Assurance Associate
6 month contract
US citizens and those authorized to work in the US are encouraged to apply.
Work sponsorship is not available at this time.
PURPOSE AND SCOPE OF POSITION:
The Quality Associate II 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 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.
• Bachelor’s degree in relevant science or engineering discipline is preferred. 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 is preferred.
• Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus.
• Hands-on experience with batch record review and product disposition is preferred.
Knowledge, Skills, and Abilities
• Strong computer skills with Word and Excel and other electronic manufacturing systems.
• Detail oriented team player with effective planning, organization and execution skills.
• Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
• Good organization and time management skills.
• Ability to work in a high paced team environment.
• Strong written and verbal skills.
DUTIES AND RESPONSIBILITIES:
• 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.
• Provide Quality support to Manufacturing personnel on the floor; provide guidance during GMP events and initiation of deviation investigations.
• Review deviations, product non-conformities, and GMP investigations to ensure adequate completion.
• 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.
• Support the review and approval of incoming raw materials, routine preventive and calibration of equipment.
• Revise Standard operating Procedures as needed.
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.
• Work in areas that may have strong magnets.
• May work in areas with exposure to vapor phase liquid nitrogen.
• Must be able to obtain gowning qualification to enter a cleanroom environment.
• May be required to work nights, weekends and holidays in a 10-hour shift structure.
• Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.