At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

Description:

The Complaints Analyst is responsible for product quality complaint triage, review, investigation, and documentation to ensure complaint files comply with regulatory requirements.  The position includes hands-on visual and functional investigation of customer complaint samples.  Other responsibilities include coordination of investigations with other departments, update of Standard Operating Procedures, data entry, and data analysis.  

Essential Job Functions:

• Physical receipt, triage, and investigation of product complaints, including used medical devices with possible biohazardous contamination, following all Universal Precautions. 
• Ensure proper documentation practices during job activities.
• Perform visual and functional inspections.
• Perform data analysis and trending.
• Conduct troubleshooting activities.
• Complete assigned training in a timely manner.
• Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions.
• Train others on documents, systems, software, equipment, machines, procedures, and/or processes.
• Answer compliance and process questions from others.
• Establish visual tracking and other tools to enhance trend analysis and audit readiness.
• Lead and coordinate investigations with little supervision.
• Lead process improvement activities and teams to meet strategic goals.
• Use SAP to verify inventory and materials.
• Actively participate in team meetings to discuss progress, initiatives, and/or other matters.
• Assist with coordinating activities of support groups.
• Identify temporary and permanent fixes to address issues.
• Monitor records to ensure compliance with regulatory requirements.
• Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.
• Participate in cross-functional teams to meet strategic goals.
• Coordinate with representatives from other departments.
• Alert others (for example: supervisor, manager) when problems occur outside of Standard Operating Procedures.
• Perform data entry.
• Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.
• Read and interpret diagrams, drawings, and other schematics.
• Check batch records for accuracy and communicate any issues to necessary parties.
• Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within functional area.
• Create, generate, type, proof, and distribute correspondences.
• Maintain accurate and complete records (for example: laboratory notebooks, quality records, sample receipts).
• Prepare regular and ad hoc reports for others.
• Review and approve quality documentation.
• Participate in maintaining lab cleanliness as required by SOPs, including use of various chemical cleaners/disinfectants.

Other Duties:

• Gather, organize, and communicate operational information to others.
• Develop lean processes and procedures.
• Interact with regulatory agency personnel during audits and inspections.
• Assist with recruiting/interviewing/evaluating prospective employees.
• Interact with other departments to implement corrective/preventative actions.
• Maintain equipment and systems along with their certification records.
• Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance.
• Provide "off shift" support (for example: night shift support if you normally work day shift).

Minimum Requirements:

Bachelors degree required in a scientific or technical discipline and 1-3 years of experience supporting quality assurance in a regulated or GMP environment.

Preferred Background:

• Previous experience in a Lean, process-centric organization with emphasis on continuous improvement
• Multi-site/multifunctional experience
• 5+ years relevant experience
• Familiarity with Medical Device regulations

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.