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QA SpecialistCollabera • United States
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QA Specialist

Collabera
  • US
    United States
  • US
    United States
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Über

Job Title
Individual will work in global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries. Top Skills Required
Complaint handling and investigation skills Cross-functional communication and organization Ability to work with internal teams, external customers, manufacturing sites, and regulatory functions while managing multiple cases and priorities Quality/compliance experience in a regulated environment Good Documentation Practices, accurate recordkeeping, and clear written communication are key because complaint files must meet global and regulatory standards Position Summary
Individual will work in global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries. Interface with internal and external 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 and identification of potential adverse events and potentially reportable events. Pay - $23/hr to $25/hr Responsibilities
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, 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
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 1-2 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. The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable. Job Requirements
CAPA GMP QA Complaint Handling Contact Information
Recruiter Email: danish.kazi@collabera.com Phone: Danish Kazi
  • United States

Sprachkenntnisse

  • English
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