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Quality Assurance Specialist
2 months ago
Position: QA Associate
Company: Crox Consulting Inc
Location: Bothell, WA*100% onsite
Schedule: Sunday-Wednesday, 9PM - 7:30AM PST
The QA Associate will play a vital role in ensuring the quality of products manufactured in compliance with industry regulations. The responsibilities include:
- Conducting thorough reviews of documentation related to manufacturing processes.
- Maintaining a presence on the shop floor to oversee quality assurance activities.
- Disposing of in-process materials and finished products as necessary.
- Investigating and resolving any discrepancies in Good Documentation Practices (GDP).
- Performing comprehensive reviews of batch records to support product release.
- Inspecting and approving intermediates or packaged drug products based on established specifications.
- Monitoring various stages of production and ensuring compliance with documentation.
- Drafting and reviewing specifications and Standard Operating Procedures (SOPs).
- Tracking and analyzing batch record errors to provide insights to Quality Assurance management.
- Offering guidance and support to junior staff members.
- Participating in daily walkthroughs of GMP areas to ensure compliance.
The ideal candidate will possess:
- A Bachelor’s degree in Biology, Chemistry, or a related field, or equivalent experience.
- A minimum of 2 years of relevant experience in a regulated environment, with a focus on product quality.
- Familiarity with biotech product manufacturing processes.
- Knowledge of US and EU cGMP regulations and guidelines.
- Experience with Oracle, BMRAM, MES, and Veeva Infinity is advantageous.
This position is suitable for recent graduates with a degree in biology or a related field who are eager to gain experience in a GMP environment.
