Regulatory Affairs Specialist

  • location: Deerfield, IL
  • type: Contract
  • salary: $45 - $47.17 per hour
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job description

Regulatory Affairs Specialist

job summary:
  • The Senior Quality Investigator (Non-medical Complaints) is responsible for assuring regulatory compliance at Company, ensuring timely and accurate completion of compliance-related activities and documentation. The Senior Quality Investigator is responsible for ensuring the thoroughness and timeliness of complaint investigations, as well as Quality investigations related to non-medical product complaints, and complaint trends. The Sr. Quality Investigator must lead cross-functional project teams to analyze the problem, coordinate and communicate receipt of data from third party contractors, review the data received, assemble statistical data regarding the investigation, evaluate similar CAPAs that may fall under the same investigation, review and approve all documentation, and communicate the results of the investigation throughout multiple levels of the organization.
 
location: Deerfield, Illinois
job type: Contract
salary: $45.00 - 47.17 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Accountable for investigating non-medical product complaints involving commercial products, ensuring the thoroughness and timeliness of these investigations.
  • Accountable for the accurate and timely trending (statistical and practical) of non-medical commercial product complaints and for timely communication of any data trends/issues to management as appropriate.
  • Responsible for liaising with third parry manufacturers/packagers to ensure thorough, accurate and timely complaint investigations.
  • Responsible for posting complaint data to the Sharepoint site in a timely manner.
  • Responsible for facilitating the investigation process (coordinating the gathering of external information, identifying cross-functional team members, facilitating team meetings, and assuring adequacy of supportive documentation) to ensure that Quality Assurance investigations for non-medical commercial complaints and complaint trends effectively identify issues, and that underlying systemic problems are adequately addressed to prevent future recurrence.
  • Responsible for identifying/reporting complaint system issues, and system changes needed to gain efficiencies. Responsible for reviewing system requirements to ensure they accurately reflect users needs. Responsible for participating in User Acceptance Testing, accurately documenting activities per governing SOPs, and policies. Responsible for providing training to new complaint system users as needed.
  • Accountable for training and communicating non-medical complaint definitions, processes, and current urgent complaint issues to Company's Call Center, PPD.
  • Responsible for the identification, development and implementation of internal quality performance metrics and associated reports to drive continuous improvement.
  • Responsible for coordinating Information Sharing with key cross-functional groups such as Supply Chain, Global Patient Safety Evaluation, (GPSE), and Medical Information to alignment between these critical areas.
  • Responsible for providing accurate complaint metrics and Quality investigation information to Quality for the Annual Product Review (APR) and to GPSE for the Annual Periodic Review (GPSE).
  • Responsible for establishing and maintaining a filing system for complaint records and trend reports. Ensures that applicable Quality procedures are updated as appropriate.
  • Responsible for appropriate escalation and communication of issues representing risk for Company.
 
qualifications:
  • Bachelors degree in science or pertinent technical field required.
  • Minimum 4 years QA or related experience in a cGMP regulated environment.
  • Minimum 3 years experience in pharmaceutical industry environment.
  • Minimum 3 years experience in managing non-medical product complaints.
  • Experience with supplier management, plant operations, metrics concepts, statistical process control and other quality engineering tools required.
  • Minimum 3 years experience with direct customer interaction.
  • Knowledge of cGMP regulations governing: drug development and manufacturing, analytical laboratory processes, packaging and labeling activities, distribution and returned goods preferred.
  • Knowledge of project management, CAPA handling, quality systems, investigation follow up and processing quality documentation systems desired.
  • Strong oral/written communication skills.
  • LICENSES/CERTIFICATIONS:

    • Knowledge and ability to utilize Microsoft Word, Excel, Access, and PowerPoint programs required.
    • ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) desirable.
    • Project Management certification desirable.
    • Experience with Citrix/Siebel based programs.
  • TRAVEL REQUIREMENTS:

    • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
    • Requires approximately ?5 % travel.
 
skills: Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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