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Regulatory Compliance Project Coordinator

2 months ago

Troy, New York, United States Innovative Process Solutions, Inc. Full time
Position Overview:
As a Regulatory Compliance Project Coordinator, you will be responsible for overseeing and strategizing projects aimed at identifying and addressing compliance challenges within the organization. Your expertise will be crucial in ensuring adherence to industry standards and regulatory requirements.

Key Responsibilities:
1. **Project Scope and Planning:** Develop comprehensive project plans to identify compliance-related issues that necessitate remediation.
2. **Risk Assessment:** Conduct thorough procedural risk assessments to evaluate potential compliance vulnerabilities.
3. **Documentation Management:** Produce essential compliance lifecycle documentation, including specifications, protocols, commissioning tests, and Standard Operating Procedures (SOPs).
4. **Training Development:** Create and implement training programs to ensure staff are well-versed in compliance standards and procedures.
5. **cGMP Documentation:** Author cGMP documentation to guarantee compliance with quality systems, operational procedures, and industry standards.

Qualifications:
Applicants should possess a Master's degree (or equivalent) in Pharmaceutical Manufacturing or a related field, along with a solid understanding of cGMP documentation practices. Experience in preparing change control test plans, validation protocols, and conducting quality risk management analyses is essential.

Compensation:
Minimum Salary: $90,000
Maximum Salary: $90,000

Salary Structure:
Annual