ROLE SUMMARY

The incumbent will conduct and document product complaint investigations. Investigations will be completed through the review of manufacturing records and associated deviations, examination of returned complaint samples, coordination of product reserve sample evaluation, and review of complaint histories and trends. The incumbent will track all product complaint investigations and assigned complaint categories. Where possible, the root cause of the complaint and corrective actions will be identified. Upon completion of these activities a final report will be prepared in accordance with established procedures.

ROLE RESPONSIBILITIES

• Understand customer / patient use of and manufacturing processes for site manufactured, packaged and/or distributed products.

• Track receipt, investigation and closure of product complaints to ensure adherence to established timelines.

• Investigate complaints and subsequently document the evaluation actions taken and conclusions reached using the defined report template.

• Conduct investigation into potential trend signals, including review of risk management file and coordination of cross-functional investigation team meetings as required per SOP.

• Where possible identify the root cause of the complaint and facilitate identification and implementation of corrective and preventive actions relative to a complaint investigation.

• Initiate and submit Quality Notification To Management records as required per procedure, including when new risks are identified during the course of the investigation.

• Track and trend complaints, including provision of trend reviews / reports to customers, site and corporate management, and for Annual Product Records Reviews.

• Perform periodic reviews of program-related SOPs / processes and revise as necessary.

• Perform gap assessments to assure alignment of site program SOPs with policy; close identified gaps through SOP revision or other actions.

• Support internal and external cGMP audits and regulatory agency inspections, and completion of post-audit / inspection commitments.

• Support additional projects and initiatives as directed by management.

BASIC QUALIFICATIONS

• Bachelor degree in Science or Engineering

• 3 years of experience in the pharmaceutical / medical device industry working in a manufacturing environment.

• Preferred incumbent will have 1+ years complaint investigation experience.

• Knowledge and understanding of regulatory compliance / cGMP requirements for pharmaceutical / medical device manufacturing processes / operations

• Demonstrated technical writing ability, preferably including experience with conduct and documentation of quality investigations

• Excellent written and communication skills

• Excellent organization skills with the ability / flexibility to react to changing deadlines and priorities

• Demonstrated critical thinking and ability to pay close attention to detail and accuracy

• Proficiency with Microsoft Word, Excel, Outlook, PowerPoint Required

Meridian Medical Technologies (MMT) is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. MMT also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

MMT requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, MMT will consider requests for Reasonable Accommodations.