QA Specialist in Austin, TX

Schedule 8:30-5PM

Hybrid 3 days on site, flexible on days in office

Top requirements- Tech savvy, 3 years lap or scientific exp, CAPA exp preferred

Responsibilities :

• List up to 10 main responsibilities for the job.
• 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

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. We specialize in attracting and retaining talent globally for rewarding careers in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, whether in the USA, UK, India, or Ireland. Additionally, we offer Location Independent jobs and contract positions across different verticals and industries.
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