Job details
Kelly is hiring for a QA Associate position with one of our clients in Bothell, WA.

• Full time- W2
  
• Shift: 2100-0730 PST, Wednesday-Saturday
  
• 12 months contract (May be extended or converted)
  
• $39.00/hr

Job Description:
The Quality Associate II position plays a key role in supporting the cGMP quality operations.? Primary 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 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.

• 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 and Education Requirements:

• 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 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.

Physical Requirements:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• 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.
  
• May Work in areas that may have strong magnets.
  
• May work in areas with exposure to vapor phase liquid nitrogen and other chemicals.
  
• Must be able to gown per requirements to enter manufacturing space.
  
• 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

Important information: This position is recruited for by a remote Kelly office , not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please apply online to be considered for the position.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. That's why we're proud to offer a complete array of voluntary benefits to members of the Kelly talent community.
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