What are the responsibilities and job description for the Sr. Regulatory Auditor position at MTF Biologics?
Overview
The Senior Regulatory Auditor performs all Regulatory Auditor functions, while creating and maintaining the internal and external audit schedules to ensure compliance with Regulatory and MTF requirements. The position is responsible for reporting on audit program KPis to Management in various meetings (Management Review) and partnering with the Supplier Quality Management Team (SQMT) to determine requirements for evaluations/audits of MTF suppliers.
This is a hybrid position. You will need to be local to Olyphant, PA. There will be between 10% - 40% travel between Olyphant, PA & Edison, NJ for audits.
Responsibilities
- Creates and maintains the internal and external audit schedules to ensure audits are performed according to applicable procedures. This includes ensuring audits are conducted according to strategic measures and metrics.
- 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).
- Facilitate audits from regulatory agencies, accreditation bodies and customers.
- Tracks corrective actions resulting from internal and external audits and reports KPI information to Management.
- Partners with SQMT to determine requirements for evaluations/audits of suppliers when added or changed.
- Responsible as the Subject Matter Expert (SME) for the Change Management (change control) System.
- Maintains knowledge of new/revised regulations and reviews procedures to determine corresponding needed updates to reflect any changes.
- Conducts training provided by Regulatory Affairs on ongoing compliance issues.
- 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
- 5 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
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., PEA Pet Insurance, Legal, home and auto insurance)
- Sword Health (at home Physical Therapy)
