QA Specialist II/Product Complaint Analyst I
Company: Planet Pharma
Posted on: August 6, 2022
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 and identification of potential
adverse events and potentially reportable events. Responsibilities
may include creation and submission of regulatory reports, creation
of customer communications and interface with various third
- 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.
- 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
- Solid written/verbal communication and organizational
- 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 Planet Group of Companies is an equal opportunity employer. We
celebrate diversity and are committed to creating an inclusive
environment for all employees.
Keywords: Planet Pharma, Austin , QA Specialist II/Product Complaint Analyst I, Professions , Austin, Texas
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