Quality Assurance Specialist

Quality Assurance Specialist 

Location: Local to Austin, TX

Individual will work in Client’s global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries. Interface with internal Client 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 Client 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 parties.

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, Client 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).

3 years’ work experience in a cGMP related industry or in a clinical setting is preferred