What are the responsibilities and job description for the Regulatory Compliance Manager position at Katalyst HealthCares and Life Sciences?
Key Responsibilities
As a Regulatory Compliance Manager at Katalyst HealthCares and Life Sciences, you will be responsible for ensuring that our company meets all regulatory requirements and maintains compliance with relevant laws and regulations.
Some of your key responsibilities will include reviewing and approving qualification activities, change controls, batch records, auxiliary forms, investigations, procedures, and other quality-related documentation. You will also be responsible for supporting aseptic operations on shift, auditing classified areas, and getting certified for Grade A/B gowning. Additionally, you may perform quarantine functions and accountability reviews, support special projects, and work with customers to resolve problems and satisfy quality and production needs.
The ideal candidate will have a Bachelor's degree in Science, Health Science, Engineering, or a related discipline with 1-3 years of industry experience. Previous experience in the pharmaceutical industry, particularly in quality assurance/engineering, technical roles, or regulatory/compliance, is highly desirable. Lean Six Sigma certification and previous experience with SAP, MEDS, etc., are also preferred qualifications.
We offer a competitive salary, benefits package, and opportunities for growth and development within our company. If you are passionate about delivering high-quality products and services while maintaining regulatory compliance, we encourage you to apply for this exciting opportunity.
As a Regulatory Compliance Manager at Katalyst HealthCares and Life Sciences, you will be responsible for ensuring that our company meets all regulatory requirements and maintains compliance with relevant laws and regulations.
Some of your key responsibilities will include reviewing and approving qualification activities, change controls, batch records, auxiliary forms, investigations, procedures, and other quality-related documentation. You will also be responsible for supporting aseptic operations on shift, auditing classified areas, and getting certified for Grade A/B gowning. Additionally, you may perform quarantine functions and accountability reviews, support special projects, and work with customers to resolve problems and satisfy quality and production needs.
The ideal candidate will have a Bachelor's degree in Science, Health Science, Engineering, or a related discipline with 1-3 years of industry experience. Previous experience in the pharmaceutical industry, particularly in quality assurance/engineering, technical roles, or regulatory/compliance, is highly desirable. Lean Six Sigma certification and previous experience with SAP, MEDS, etc., are also preferred qualifications.
We offer a competitive salary, benefits package, and opportunities for growth and development within our company. If you are passionate about delivering high-quality products and services while maintaining regulatory compliance, we encourage you to apply for this exciting opportunity.
