Associate Quality Analyst I
Product Complaint Lab Analyst I
Individual will work in global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries. Interface with internal customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization and PV regarding product complaints. Responsible for product complaint documentation, investigations, identification of product defects and/or damage, and summarizing investigational data into a complaint handling system. Responsibilities may include interface with various third parties.
Product complaint documentation, investigation, and review of all non-medical complaint content.
Responsible for reviewing complaints that involve a non-medical quality related problem.
Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GLP. This requires good analytical skills, technical writing, and good documentation.
Responsible that complaint data meet all regulatory requirements.
Comfortable working with sharps (e.g. needles) that are potentially biohazardous.
Identification of potentially reportable events and notification to appropriate functional groups and management.
Interface with Third Party Manufacturers, internal customers, and internal functional areas.
Solid written/verbal communication and organizational skills.
Knowledge and application of computer systems for word processing and complaint management.
Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
A Bachelor Degree required. Preferred degree in technology or scientific background
Experience working in a testing lab environment preferred
0-3 years work experience in a cGMP related industry or in a clinical setting is preferred
Experis is an Equal Opportunity Employer (EOE/AA)