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QA Specialist II/Product Complaint Analyst I

North Chicago, IL 60085

Posted: 08/29/2022 Employment Type: Contract Job Category: Quality and Compliance Job Number: 508566-1 Is job remote?: No Country: United States

Job Description


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 problem. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.
•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.
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 Degree required. Preferred degree in technology or scientific background (MLT, LPN, RN).
•0-3 years’ work experience in a cGMP related industry or in a clinical setting is preferred

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About North Chicago, IL

Ready to take the next step in your career? Explore job opportunities in and around North Chicago, Illinois, where growth knows no bounds. Nestled along the shores of Lake Michigan, this vibrant area offers a blend of urban excitement and natural beauty. Home to iconic landmarks like Navy Pier and the Art Institute of Chicago, plus renowned theater venues like the Chicago Shakespeare Theater and iconic sports teams like the Cubs and Bulls, North Chicago boasts a rich cultural tapestry. Indulge in the local deep-dish pizza or take a stroll through Millennium Park; this region truly has something for everyone. Join us in discovering the endless possibilities for personal and professional growth in North Chicago - where careers flourish and dreams take flight.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.