QA Shop Floor Specialist
Company: Aequor Technologies
Location: Bothell
Posted on: May 7, 2024
Job Description:
**Schedule- 9:00pm - 7:30am, Sun - Wed**
**Top Skills:
- 3-5 years of GMP work experience
- Familiarity with Batch Records
- Deviations Experience Preferred
- ssociates or BA Degree preferred, or HS Diploma + relevant work
experience Soft skills include- strong cross-functional experience,
strong interpersonal skills
Job Description: **Schedule- 9:00pm - 7:30am, Sun - Wed**
**Top Skills:
- 3-5 years of GMP work experience
- Familiarity with Batch Records
- Deviations Experience Preferred
- ssociates or BA Degree preferred, or HS Diploma + relevant work
experience
- Soft skills include- strong cross-functional experience, strong
interpersonal skills
*Job 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.
*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.
- 3-5 years of relevant cGMP experience. Experience in FDA/EMA
regulations in biopharmaceuticals or cell therapy manufacturing is
preferred.
- Hands-on experience with batch record review and product
disposition is preferred.
- 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.
- bility 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.
- 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.
Additional Job Requirements:
Keywords: Aequor Technologies, Kirkland , QA Shop Floor Specialist, Other , Bothell, Washington
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