QA Specialist

Description

Schedule 8:30-5PM

Hybrid 3 days on site, flexible on days in office

• Masters degree can be also work if they are interested
• Lake county
• familiar with FDA is plus
• want someone with Quality mindset
• QA is an experience
• some overtime
• Received global complaints for product related
• Focus outbound calls, internal communication, generate emails, investigations, etc.
• Process 40-50 cases in daily basis
• High volume role
• Manage daily KPIs
• Global meeting little bit early
• A bachelor’s degree is preferred
• familiar with Capa experience
• Any Quality experience will work but preference is regulated industry
• 2 year of exprinec
• Hybrid role
• Training module: couple of week like Abbvie policy, documentation, GDP, modules, processors, records sample, etc. (min 6 weeks)

Responsibilities :

• Include information about the accountability and scope.
• Assure complaint records meet global requirements.
• Product complaint documentation, investigation, and review of all non-medical complaint content.
• Responsible for reviewing Medical complaints that involve a non-medical quality related event.
• Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP.
• This requires good analytical skills, technical writing and good documentation.
• Responsible that complaint files meet all regulatory requirements.
• Identification of potentially reportable events and notification to appropriate functional groups and management.
• Interface with Third Party Manufacturers, health care professionals, general public, internal customers, Client functional areas and regulatory agencies.
• Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product, complaint categorization, and CAPA.

Qualifications

• List required and preferred qualifications up to 10).
• Include education, skills and experience.
• Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
• Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device
• Reporting regulations (21 CFR 803, 820 and 211) is preferred.
• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
• 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's Degree required or 1-3 years of relevant work experience.
• Preferred degree in technology or scientific background (MLT, LPN, RN).
• 0-2 years’ work experience in a cGMP related industry or in a clinical setting is preferred