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Regulatory Specialist I - Salt Lake City, UT

Quick Facts
Company Name:Nelson Labs
Location:Salt Lake City, UT
Employment Type:Full Time
Category:Other
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Description

At Nelson Laboratories, a Sotera Health Company, our employees are part of an industry-leading, global provider of sterility assurance, medical device evaluation services and expert advisory services.

Our employees receive competitive pay, growth and learning opportunities, insurance benefits, tuition reimbursement, paid holidays, time-off and the opportunity to attend many company-sponsored employee and family events.

Nelson Labs employees play a critical role in reaching our mission of: Safeguarding Global Health.

Summary

Regulatory Affairs oversees the quality system and uses a risk based approach to ensure regulatory compliance for Nelson Labs. Department processes include function support, internal audits, external audits, agreements, change management, failure investigations and environmental monitoring, proficiency testing, quality events, supply/supplier management, corrective and preventive actions, complaints, management review, and regulatory interactions.

The Regulatory Specialist II is responsible for quality system and investigation processes, which may include agreements, change management, failure investigations and environmental monitoring, proficiency testing, quality events, supply/supplier management, complaints and/or CAPA. The Regulatory Specialist II also supports the audit-ready philosophy of the company through participation in the internal and external audit processes and provides support to company functions as needed. The Regulatory Specialist II acts as the deputy for the Regulatory Specialist I and contributes to other Regulatory Affairs processes as needed.

Essential Job Duties

Regulatory Compliance

  • Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
  • Know and follow company policies and procedures.

Agreements

  • Review, negotiate, approve and track quality, lab, service and change agreements
  • Change Management
  • Review, approve and close requests
  • Perform risk assessments
  • Maintain documentation and files

Failure Investigations/Environmental Monitoring

  • Perform Product Sterility failure and sample positive investigations to determine if positives are attributed to the laboratory
  • Organize and present failures to established committee
  • Approve Product Sterility result changes
  • Oversee compliance for Product Sterility environmental monitoring program
  • Analyze monthly excursion trends and perform excursion investigations
  • Complete quarterly summary report
  • Ensure appropriate actions are taken in a timely manner in response to trends

Proficiency Testing

  • Coordinate and ensure completion of testing to asses and demonstrate the reliability of data and to satisfy accreditation requirements
  • Review data and report to accreditation body and Quality Committee

Quality Events

  • Perform quality event investigations for deviations, OOS and unexpected values
  • Perform risk assessment to determine if full investigation and/or corrective/preventative action is necessary
  • Perform trend analysis as needed

Supplier/Supply Management

  • Manage the Qualified Supplier List, approve new suppliers and perform annual assessments of suppliers
  • Assist with the qualification process for essential suppliers and subcontractors and perform on-site audits as needed
  • Perform quality control responsibilities for supply management

Corrective and Preventive Actions

  • Coordinate, initiate, investigate and own corrective and preventive actions
  • Work with area managers to perform root cause analysis and develop action plans
  • Complete actions in a timely manner through all stages of processes
  • Complaints
  • Coordinate, initiate and investigate complaints
  • Work with area managers to perform root cause analysis and develop action plans
  • Respond to the customer within a required deadline
  • Ensure customer satisfaction during complaint resolution
  • Ensure timely implementation of action plans

Function Support

  • Maintain a quality partnership with each assigned function by performing monthly trend review, dashboard and collaborating on quality issues

Internal Audits

  • Conduct audits in accordance with yearly audit schedule
  • Prepare audit agendas and make assignments to audit team members
  • Sample items to audit based on risk to the company and failure modes of the system
  • Conduct audits with a high degree of professionalism and courtesy
  • Review and ensure findings are properly classified and apply the appropriate level of action necessary based on risk
  • Ensure audit reports are completed, distributed, and all action items closed prior to close of audit file
  • Track and trend audit metrics

External Audits

  • Involve pertinent staff throughout the audit process to facilitate knowledge transfer
  • Conduct a tour of the facility as requested by the auditor
  • Provide necessary documents and information to the auditor as requested
  • Assist with any follow up needed after the live phase of the audit
  • Ensure all documents are returned to their appropriate place directly after the audit
  • Prepare or complete information for written audit requests
  • Prepare responses to audit reports
  • Track and trend audit metrics

Professional Development

  • Complete required training on time (includes Master Control tasks, on the job training, live company training, New Employee Orientation, etc.)

Perform other duties as assigned.

Education and Qualifications

High School Diploma or equivalent and four years quality experience OR A.S with three years quality experience OR B.S with two years quality experience. CQA or equivalent certification preferred.

This position also requires:

  • Demonstrated knowledge of GMP, GLP, and ISO 17025 regulatory requirements
  • Ability to effectively work with and support customers, members of staff and management with professional courtesy
  • Ability to apply regulations in a valuable way to the company
  • Ability to prioritize tasks from a risk based approach and consistently meet deadlines
  • Ability to accept constructive criticism and to implement and learn quickly from feedback
  • Demonstrated knowledge of trend analysis to identify and act on recurring issues
  • Ability to be proactive in continuous improvement of systems, processes, and procedures
  • Must be solution driven
  • Must have excellent response times and service for internal and external customers
  • Ability to communicate internally and externally in a careful, clear and objective manner
  • Professional and helpful in attitude
  • Dependability in hosting audits as scheduled and until audit is complete
  • Proficient in Microsoft programs and typing.

Physical Requirements

Must be able to spend 30-40% standing and walking the lab on audit days and 10% on non-audit days. Must be able to sit 60-70% on audit days and 90% on non-audit days and 50% on the computer on audit days and 90% on the computer on non-audit days. Also, must be able to lift a minimum of 20lbs.



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