- 3-5 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.
- 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.
-
QA Shop Floor Specialist
4 weeks ago
Aequor Bothell, United StatesPosition: QA Shop Floor Specialist · Location: Bothell WA 98021 · Duration: 6 months (possibility of extension for the right candidate depending on performance) · Pay rate: $42.41/ hour on W2 · **Schedule- 9:00 pm - 7:30 am, Sun-Wed** · **Top Skills: · 3-5 years of GMP work expe ...
-
QA Shop Floor Specialist
1 week ago
Integrated Resources, Inc ( IRI ) Bothell, United StatesTitle: QA Shop Floor Specialist · Location: Bothell, WA · Duration: 12 months · Shift: 9 PM to 7:30 AM PST Wed to Sat. · Skills: 1–3-year GMP exp, 1-3 batch record, clean room, or other controlled spaces. Also consider fresh grad. · Familiarity with Batch Records · Deviations Exp ...
-
QA Shop floor Specialist
4 weeks ago
Sunrise Systems, Inc. Bothell, United StatesSunrise System Inc. is currently looking for QA Shop floor Specialist in Bothell, WA, Onsite with one of our top client. · Job Title: QA Shop floor Specialist · Location:Bothell, WA, Onsite · Duration: 6+ months · Position Type: Hourly contract Position (W2 only) · Job Descript ...
-
QA Shop floor Specialist
3 weeks ago
Sunrise Systems Bothell, United StatesSunrise System Inc. is currently looking for QA Shop floor Specialist in Bothell, WA, Onsite with one of our top client. · Job Title: QA Shop floor Specialist · Location:Bothell, WA, Onsite · Duration: 6+ months · Position Type: Hourly contract Position (W2 only) · Job Descr ...
-
QA Shop Floor Specialist
2 weeks ago
Sunrise System inc Bothell, United States**Schedule- 9:00pm - 7:30am, Sun - Wed** · **Top Skills: · 3-5 years of GMP work experience · Familiarity with Batch Records · Deviations Experience Preferred · Associates or BA Degree preferred, or HS Diploma + relevant work experience · Soft skills include- strong cross- ...
-
QA Shop Floor Specialist
2 weeks ago
Eclaro Bothell, United StatesQA Shop Floor Specialist · Job Number: · Be part of a company that delivers life - changing healthcare solutions. Eclaro is looking for a QA Shop Floor Specialist for our client in Bothell, WA. · Eclaro's client is among the world's largest pharmaceutical companies, trusted by ...
-
QA Shop Floor Specialist
3 days ago
American Cybersystems Bothell, United StatesInnova Solutions is immediately hiring a QA Shop Floor Specialist. · Job Title: QA Shop Floor Specialist · Position type: Full-time Contract · Duration: 06 Months · Location: Bothel, WA · Pay range: $40 -$ 43.33 Per Hour · Work Schedule: 9:00pm - 7:30am, Sun - Wed · As a QA ...
-
QA Shop Floor Specialist
3 weeks ago
Axelon Bothell, United StatesPay range: $40 to $44 per hour on *** · 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 · - Associates or BA Degree preferred, or HS Diploma ...
-
QA Shop Floor Specialist
3 weeks ago
TSR Consulting Bothell, United StatesAbout TSR: TSR is a relationship-based, customer-focused IT and technical services staffing company. For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of compan ...
-
QA Shop Floor Specialist
2 weeks ago
LanceSoft Bothell, United StatesTitle: Quality - QA Shop Floor Specialist · Location: Bothell, WA 98021 · Duration: 06 Months · Comments:Schedule- 9:00 pm - 7:30 am, Sun-Wed · Top Skills:3-5 years of GMP work experience. · Familiarity with Batch Records · Deviations Experience Preferred · Associate or BA Deg ...
-
QA Shop Floor Specialist
3 weeks ago
Aequor Inc Bothell, United StatesPosition: QA Shop Floor Specialist · Location: Bothell WA 98021 · Duration: 6 months (possibility of extension for the right candidate depending on performance) · Pay rate: $42.41/ hour on W2 · **Schedule- 9:00 pm - 7:30 am, Sun-Wed** · **Top Skills: · 3-5 years of GMP wor ...
-
QA Shop Floor Specialist
1 week ago
Axelon Bothell, United StatesPay range: $40 to $44 per hour on *** · 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 · - Associates or BA Degree preferred, or HS Diploma + rel ...
-
QA Shop Floor Specialist
3 weeks ago
TSR Consulting Bothell, United StatesAbout TSR: · TSR is a relationship-based, customer-focused IT and technical services staffing company. · For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of co ...
-
QA Shop Floor Specialist
3 weeks ago
Pyramid Consulting, Inc Bothell, United StatesImmediate need for a talented QA Shop Floor Specialist. This is a 06+ Months Contract opportunity with long-term potential and is located in Bothell, WA(Onsite). Please review the job description below and contact me ASAP if you are interested. · Job ID: · Pay Range: $35 - $42/h ...
-
QA Shop Floor Specialist
2 days ago
Axelon Services Corporation Bothell, United StatesPay range: 35$ to 41$/hr. · Job Description: · Shift is from 9 Pm-7:30 Am Wed-Sat · The QA Shop Floor Specialist is responsible for quality activities supporting Manufacturing Operations in accordance with *** policies, standards, procedures, and Global cGMP. Functional responsib ...
-
QA Shop Floor Specialist
3 weeks ago
System One Holdings, LLC Bothell, United StatesJob Title: QA Shop Floor Specialist · Location: Bothell, WA · Hours/Schedule: 9:00pm - 7:30am, Sun - Wed · Compensation: $ $42.41/hr · Type: Contract, Potential for extension or conversion to permanent · Responsibilities Review executed batch records to ensure compliance wit ...
-
QA Shop Floor Specialist
4 days ago
Axelon Services Corporation Bothell, United StatesPay range: 35$ to 41$/hr. · Job Description: · Shift is from 9 Pm-7:30 Am Wed-Sat · The QA Shop Floor Specialist is responsible for quality activities supporting Manufacturing Operations in accordance with *** policies, standards, procedures, and Global cGMP . Functional res ...
-
QA Shop Floor Specialist
4 weeks ago
System One Bothell, United StatesJob Title: QA Shop Floor Specialist · Location: Bothell, WA · Hours/Schedule: 9:00pm - 7:30am, Sun - Wed · Compensation: $ $42.41/hr · Type: Contract, Potential for extension or conversion to permanent · Responsibilities · + Review executed batch records to ensure compliance with ...
-
QA Shop Floor Specialist
2 weeks ago
Aequor Technologies Bothell, United States**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-functi ...
-
QA Shop Floor Specialist
2 weeks ago
Integrated Resources Bothell, United StatesJob Description: **Schedule- 9:00pm - 7:30am, Sun - Wed** · **Top Skills: · - 3-5 years of GMP work experience · - Familiarity with Batch Records · - Deviations Experience Preferred · - Associates or BA Degree preferred, or HS Diploma + relevant work experience · - Soft skills in ...
QA Shop Floor Specialist - Bothell, United States - Integrated Resources, Inc ( IRI )
Description
Job Title: QA Shop Floor Specialist
Job Location: Bothell, WA
Job Duration: 6 Months+
Schedule- 9:00pm - 7:30am, Sun - Wed
Top Skills:
3-5 years of GMP work experience
Familiarity with Batch Records
Deviations Experience Preferred
Associates 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 associate degree and/or equivalent combination of education and experience is required.
ROLES AND RESPONSIBILITIES:
