QA Associate

2 weeks ago


Bothell, United States Collab Infotech Full time
Job DescriptionJob Description

We have an Immediate opening for a "QA Associate" with one of the Top 10 leading Pharmaceutical companies in Bothell, WA, for a 12 Months contract.

 

 

 

 

Job Description:

Job Title: QA Associate

Location: Bothell, WA

Duration: 12 Months 

Pay Rate: $34.96/hr on W2

 

 

 

 

 

 

Job Description:

Job Title: QA Associate

Location: Bothell, WA*100% onsite

Work Schedule: Sunday-Wednesday, 9PM - 7:30AM PST*



Top Skills -

  • Documentation Review experience
  • Scientific Degree
  • Experience working in a GMP environment



*Okay with candidates out of college who have a biology or similar degree who are looking for GMP experience.*

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.

  1. 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.
  2. Inspects and releases intermediates or packaged drug product per specifications.
  3. Monitors various stages of processing along with the appropriate paperwork in compliance with specifications.
  4. Drafts and reviews specifications and SOPs.
  5. Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data.
  6. May provide guidance to less experienced staff.
  7. Provides sitewide support during daily walkthroughs of GMP areas.



Requirements:

  • 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

 

 

 

 

 

 

Company DescriptionCollab Infotech specializes in Clinical, Scientific, Healthcare & IT staffing services to leading companies and Facilities. We are Tier1 supplier to 5 of the Top 10 leading companies in Pharma.Company DescriptionCollab Infotech specializes in Clinical, Scientific, Healthcare & IT staffing services to leading companies and Facilities. We are Tier1 supplier to 5 of the Top 10 leading companies in Pharma.
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