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Regulatory Auditor (Jessup Facility)

Overview/Risks

To verify MTF?s quality system is established, implemented and maintained in compliance with applicable government and state regulations, FDA, ISO 13485, TGA, Health Canada, AATB, and other industry standards, as applicable, along with auditing of critical suppliers to MTF.



Responsibilities


  1. Plans, performs, reports and follow up on audits of internal operations to ensure procedural, standards, and regulatory compliance (cGMP, QSR, cGTP, ISO, CMDCAS, and AATB Standards, as applicable)

  2. Plans, performs, reports and follow up on audits of suppliers and external organizations to ensure procedural, standards, contractual, and regulatory compliance.

  3. Provides internal communication regarding compliance issues and applicable regulation changes.

  4. Host, coordinate and facilitate audits from regulatory agencies, accreditation bodies and customers.?

  5. Coordinate and handling of Corrective and Preventive actions (CAPA and Nonconformances).? This may include any of the following: database and file controls, identification, investigation, reporting, regulatory notification, customer interface, corrective action, follow up and closure.

  6. Provides reports for audits and CAPA trend analysis to Management for inclusion in the decision-making processes.

  7. Compose, revise, review or approve Quality Assurance Standard Operating Procedures, change control specifications, validations, work instructions and forms as needed.? Assists other departments with procedure controls as requested.

  8. Provides training and/or support on quality assurance and regulatory affairs topics.

  9. Represents MTF on matters of quality with QA and RA personnel, other departments within MTF, procurement agencies, and suppliers of goods and services used in tissue and medical device processing and distribution.

  10. Assists on special projects and performs other duties as assigned.




MINIMUM JOB REQUIREMENTS


Education:


Bachelor?s degree required


Experience:


3+ years of quality assurance ? or FDA regulatory experience required


Specific Licenses and/or ? Certifications:


Specialized Knowledge, Skill, and ? Abilities :



  • ? Excellent ? communication, organizational and technical writing skills.

  • ? Must ? be computer literate, including Microsoft Word, Excel, PowerPoint, Visio and ? Access


Work Environment:


Office Environment, Laboratory ? Environment


Physical Demands:


(if ? applicable)


Travel ? required.? 25-50% of time traveling to remote locations for audits, seminars, training, etc.


PREFERRED QUALIFICATIONS


Education:


Bachelor?s Degree ? in Science or Engineering, or equivalent ?


Experience:



  • ??

  • 5+ years working in the ?????? area of quality or regulatory assurance for a regulated industry

  • ??

  • ?2+ years conducting medical device ?????? quality system audits.


Specific Licenses and/or ? Certifications:



  • ??

  • Industry certification (i.e., ASQ-CQA, CQE;CTBS).?

  • ??

  • Successful completion ?of a recognized Lead Auditor Course


Specialized Knowledge, Skill, and ? Abilities:



  • Strong assessment techniques (examination, question, evaluate, report)

  • Ability to react effectively in stressful situations and make clear, well-founded decisions regarding conformity during the audit.

  • Ability to handle multiple projects and delivering results on time

  • Pro-active attitude and excellent organizational skills




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