What are the responsibilities and job description for the Regulatory Auditor position at MTF Biologics?
Overview
The Regulatory Auditor position assures that MTF complies with all applicable standards and regulatory requirements. The position is responsible for planning and conducting internal process/ product audits and external assessment/ audits of Suppliers critical to the business. Key responsibilities include independently coordinating the review, development, and performance of audits in accordance with procedures and authoring audit reports to management reflecting the results of the work performed, including audit findings and decisions regarding corrective/ preventive actions, and the effectiveness of those actions put into practice.
This is a hybrid position. You will need to be local to Edison, NJ. There will be between 10% - 40% travel between Edison, NJ & Olyphant, PA for Audits.
Salary: $78,400
Responsibilities
- Responsible for independently developing plans, performing audits, and creating reports of audits on internal operations. This includes ensuring compliance with procedural, standard, and regulatory requirements (cGMP, QSR, cGTP, ISO, MDSAP, and AATB Standards, as applicable)
- Responsible for independently developing plans, performing audits, and creating reports of audits on suppliers. This includes ensuring compliance with regulatory, standard, and MTF Biologics requirements (cGMP, QSR, cGTP, ISO,
- MDSAP, and AATB Standards, as applicable)
- Partners with SQMT to confirm requirements for evaluations/audits of suppliers when added or changed.
- Assists in hosting/facilitating audits from regulatory agencies, accreditation bodies and customers.
- Makes decisions regarding corrective/ preventive actions, and the effectiveness of those actions put into practice.
- Conducts training provided by Regulatory Affairs on ongoing compliance topics.
- Maintains knowledge of new/revised regulations and reviews procedures to determine corresponding needed updates to reflect any changes.
- Assists on special projects and performs other duties as assigned.
Qualifications
- Bachelor's degree in science, Engineering, Technology, or other Health-Related Field or a Combination of Education and/or Equivalent Work Experience
- 3 years Quality or Regulatory responsibility in an FDA-regulated industry
- CQNCQE, CTBS, Exemplar Global, or similar certification preferred
- Excellent communication, organizational and technical writing skills Proficiency in Microsoft 365 application
- Strong knowledge of FDA regulations and ISO Standards
- Ability to communicate, prioritize, and organize effectively
- Ability to travel to PA.
Benefits Information
At MTF Biologics we provide comprehensive benefits and resources to support our employees physical, emotional, and financial health.
- 4 weeks Paid Time Off (PTO)
- Paid Holidays
- Medical, Dental, Vision Insurance and Prescription Drug Insurance
- 401K plan with company match
- Short- & Long-Term Disability
- Life & Accidental Death Insurance
- Tuition Reimbursement
- Health Care/Dependent Care Flexible Spending Accounts
- Adoption Assistance
- Voluntary Benefits (e.g., EAP, Pet Insurance, Legal, home and auto insurance)
- Sword Health (at home Physical Therapy)
Salary : $78,400
