Omni Inclusive
Quality - QA Associate
Omni Inclusive, Bothell, Washington, United States, 98021
Shift Schedule is 2100-0730, Wednesday-Saturday
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, 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.
QUALIFICATION REQUIREMENTS (Knowledge, Skills and Abilities):
EducationBachelor's degree in relevant science or engineering discipline is preferred. Minimum of Associates degree and/or equivalent combination of education and experience is required.Experience• 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.
Roles 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.• 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.
Working Conditions• 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.
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, 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.
QUALIFICATION REQUIREMENTS (Knowledge, Skills and Abilities):
EducationBachelor's degree in relevant science or engineering discipline is preferred. Minimum of Associates degree and/or equivalent combination of education and experience is required.Experience• 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.
Roles 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.• 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.
Working Conditions• 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.