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- Familiarity with Batch Records
- Deviations Experience Preferred
- Associates or BA Degree preferred, or HS Diploma + relevant work experience
- Soft skills include strong crossfunctional experience, strong interpersonal skills
- 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.
- Ability to work in a high paced team environment.
- Strong written and verbal skills.
- 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.
- Night shift
- In-person
- Associate (Required)
- GMP/
- Batch records: 3 years (Required)
QA Shop Floor Specialist - Bothell, United States - Sunrise Systems, Inc
Description
*Job Title: QA Shop Floor Specialist**Location: Onsite role in Bothell, WA**Duration: 6 months (With possible extension )*Pay rate: $42/hour on W2**Position Type: Hourly contract Position (W2 only)
*\*\*Schedule- 9:00pm - 7:30am, Sun - Wed\*\***\*\*Top Skills: - 3-5 years of GMP work experience
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.
*Compensation: Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].
*Benefits: Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.
*IND\_EGNIT*Job Type: Contract
Pay:
$ $42.00 per hour
Schedule:
Work setting:
Education:
Experience:
CGMP:
3 years (Required)
Work Location:
In person