Regulatory Compliance Officer
4 days ago
We are seeking a highly motivated and detail-oriented QA Associate II to join our quality team at Coating Place. As a QA Associate II, you will be responsible for supporting our quality initiatives, including compiling quality metrics, editing and reviewing SOPs, protocols, and reports, and performing raw material and product release. 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.
Key Responsibilities:
- Compile quality metrics and report on key performance indicators.
- Edit and review SOPs, protocols, and reports to ensure accuracy and compliance.
- Perform raw material and product release, ensuring adherence to company policies and procedures.
- Support investigations and complaint resolution, as necessary.
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.
Our Benefits:
- Competitive salary: $60,000 - $70,000 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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