Senior Quality Associate

3 weeks ago


Verona, Wisconsin, United States Coating Place Full time
About the Company

Coating Place is an established pharmaceutical contract manufacturer specializing in Wurster fluid bed processing and delivery system development. Our mission is to provide innovative development and manufacturing capabilities with an integrated quality philosophy. We are committed to delivering high-quality products to our customers while maintaining a safe and healthy work environment.

Job Description:
The QA Associate II is a key member of our quality team, responsible for ensuring the accuracy and integrity of our processes and products. This role requires a strong understanding of regulatory requirements and industry best practices. If you are passionate about quality and customer satisfaction, we encourage you to apply.

Responsibilities:
  • Compile and analyze quality data to identify trends and areas for improvement.
  • Edit and review SOPs, protocols, and reports to ensure accuracy and compliance.
  • Support internal audits and investigations, as necessary.
  • Maintain accurate records and documentation of quality activities.

Requirements:
  • Bachelor's degree in life or physical sciences (e.g., pharmaceutical sciences, chemistry, analytical sciences).
  • Minimum 2 years of experience in cGMP quality, compliance, and/or regulatory affairs.
  • Understanding of FDA 21 CFR regulations, ICH guidelines, EU, and Canadian GMPs.
  • Proficient in Microsoft Word, Excel, SharePoint, and PDF programs.
  • Strong written, verbal, and interpersonal communication skills.

What We Offer:
  • Competitive salary: $58,000 - $68,000 per year.
  • Medical, dental, vision, life, AD&D, and disability insurance.
  • Pre-tax 401(k) and after-tax Roth 401(k) contribution options with company matching up to 5%.
  • Generous paid-time off (up to 17 days within the first year).


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