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QA Associate
Bothell, WA
Contract/Freelance Project Description
Job Title: QA Associate
Job ID: 24-02273
Location: Bothell, WA, 98021
Duration: 12 Months contract on W2
This is an Onsite role
Work Schedule: Wednesday - Saturday, 6AM - 4:30PM PST
Maintains shop floor quality presence; disposition in-process materials and finished product; investigates and resolves GDP errors; Performs batch record reviews. Assures the quality of manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for a hosting of regulatory and customer audits.
The hourly rate for this position is between $30.00 – $35.00 per hour.
Compensation:
Factors that 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.
Job ID: 24-02273
Location: Bothell, WA, 98021
Duration: 12 Months contract on W2
This is an Onsite role
Work Schedule: Wednesday - Saturday, 6AM - 4:30PM PST
Maintains shop floor quality presence; disposition in-process materials and finished product; investigates and resolves GDP errors; Performs batch record reviews. Assures the quality of manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for a hosting of regulatory and customer audits.
- Performs general and/or more complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs.
- Inspects and releases intermediates or packaged drug product per specifications.
- Monitors various stages of processing along with the appropriate paperwork in compliance with specifications.
- Drafts and reviews specifications and SOPs.
- Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data.
- May provide guidance to less experienced staff.
- Provides sitewide support during daily walkthroughs of GMP areas.
- B.S., in Biology, Chemistry or related discipline, or its equivalent is preferred.
- 2+ years of relevant experience in a regulated environment with at least 2 years focused on product quality.
- Knowledge of biotech product manufacturing.
- Knowledge of US and EU cGMP regulations and guidance.
- Knowledge of Oracle, BMRAM, MES, Veeva Infinity are a plus
The hourly rate for this position is between $30.00 – $35.00 per hour.
Compensation:
Factors that 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.
Contact Information
Contact:
V R Manjunathan | Direct: (732)-860-1831 | Email: vrmanju@sunrisesys.com| URL: www.sunrisesys.com
Job Summary
Company
Start Date of This Project
As Soon As possible
Project Mode
Project/Job Outsourcing
Type of Project
Full Time
Hours per Week
40
Project Payroll Preference
W-2
Project Pay Range
$30.00 – $35.00
Project Work Location
On-Site
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