What are the responsibilities and job description for the Quality - QA Associate position at Omni Inclusive?
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) :
Education
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.
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
Working Conditions
