Senior QC Chemist - Complaints

Role Summary

The Senior QC Chemist - Complaints is responsible for independently performing laboratory procedures in compliance with governing Standard Operating Procedures (SOPs) and cGMP requirements. This position’s primary responsibility is managing product complaints and is secondarily responsible in serving as a back up for QC laboratory testing and verification activities. This position applies advanced analytical knowledge and experience to support material and product testing, mentor entry-level analysts, coordinate routine and project-related work, and provide feedback to the Site Quality Leader.

Responsibilities

• Perform and manage the intake, triage, and investigation of product complaints, documenting these activities in the electronic Quality Events system
• Communicate with the complainant (e.g., patient, health care provider) to procure information and complaint unit in support of product complaint investigations and outcomes.
• Performs the complaint investigations on returned product and provides direct support for the investigation of high criticality cases aligning with relevant groups to identify root case and corrective action. Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information.
• Identify possible reportable events (Field Alert/Recall) and support the reporting to applicable health authorities in accordance with GMPs for complaint handling and medical device reporting.
• Review completed complaint files to assure proper documentation, coordination, investigation, resolution, and closeout and ensure compliance to regulatory requirements as well as business requirements.
• Responsible for written and oral communication with the customer and internal/external groups.
• Perform monthly reconciliation of product complaints and adverse events/safety information with Medical Safety/Drug Safety to ensure all cases have been properly reported.
• Support the development, implementation, and continuous improvement of product complaint procedures and periodically assess and revise to ensure its effectiveness.
• Gather data to assist with any potential recall and/or reporting actions and regulatory submissions. Maintain inspection readiness. Participate in mock audits and QA audits and represents area of major responsibility.
• Perform analytical testing on raw materials, in-process samples, and finished products according to approved procedures.
• Review laboratory data to ensure compliance with approved methods, protocols, and SOPs.
• Mentor and provide guidance to less experienced analysts to ensure adherence to quality and compliance standards.

Skills

• Communication
• Competitive Drive
• Customer Service Orientation
• Integrity
• Leadership
• Safety
• Strategic Thinking
• Teamwork

Functional Competencies

• Ability to follow and prepare written procedures.
• Strong organizational, communication, and interpersonal skills.
• Ability to manage multiple projects and competing priorities.
• Thorough understanding of laboratory cGMP requirements.
• Data Affinity
• Project and Process Management
• Quality Standards and Best Practices

Qualifications

• Bachelor‚Äôs degree in Chemistry or closely related field.
• 5+ years of experience in an analytical chemistry lab within a pharmaceutical or similarly regulated environment.
• Experience developing laboratory procedures and systems preferred.

Physical Demands

• Ability to handle fine glassware and sampling devices with care.
• Ability to perform data entry.
• Ability to lift up to 20 lbs.

Travel

• Occasional travel may be required.

Working Conditions

• Laboratory environment.