- 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.
- 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.
- Ability to work in a high paced team environment.
- Strong written and verbal skills.
-
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
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: $3 ...
-
QA Shop Floor Specialist
3 weeks ago
Sunrise System inc 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 inclu ...
-
QA Shop Floor Specialist
4 days 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
3 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
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
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
Integrated Resources, Inc ( IRI ) Bothell, United StatesJob 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 preferr ...
-
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
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 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
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
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
1 week 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
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
1 week 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
6 days 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
1 week 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/hour ...
-
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
3 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 - Bothell, United States - Pyramid Consulting, Inc
Description
Immediate 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/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
Key Requirements and Technology Experience:
Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
