we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Complaints Analyst
in West Chester, OH
, you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives.
Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
Main Duties and Responsibilities As a Complaints Analyst your responsibilities include investigations that are hands on with returned product, visual and functional in nature and paper based for complaints that have no returned products. Responsible for daily acceptance of complaints in various databases and data entry on product complaint investigations for clinical and commercial products for both US and non-US markets as designated. Ensures completeness of case data entry and correctness of category selections. Follow-up on aged investigations pending resolution and closure. Update work instructions and SOPs as needed.
- Physical receipt, triage and investigation of product complaints, including used medical devices with possible biohazardous contamination, received on site. Follow all Universal Precautions.
- Ensure proper documentation practices during job activities.
- Perform visual and functional inspections.
- Verify count, measure and check materials to ensure proper components, quantities, and/or characteristics.
- Conduct troubleshooting activities.
- Responsible for completing assigned training in a timely manner.
- 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 Audit readiness and trend analysis.
- Lead and coordinate investigations and studies with little supervision.
- Lead process improvement activities and teams to meet strategic goals.
- Use SAP to verify inventory and materials.
- Actively participate 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.
- Alert others (for example: supervisor, manager) when problems occur outside of SOPs (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 a 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.
- Gather, organize, and communicate operational information to others.
- Develop lean processes and procedures.
- Interact with regulatory agency personnel during audits and inspections.
- Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
- Assist with recruiting/interviewing/evaluating prospective employees.
- Coordinate with representatives from other departments.
- 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).
- 4-year degree in a scientific or technical discipline in progress
- 3 years of experience supporting quality assurance in a regulated or cGMP environment.
- Previous experience in a Lean, process-centric organization with emphasis on continuous improvement
- Multi-site/multifunctional experience
- 10+ years relevant experience
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.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
A little about us:
At AstraZeneca, we believe the best way we can help patients is to focus on breakthrough science in order to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines.