QA Inspector

ARNET PHARMACEUTICALS CORP•Davie, FL

4d•Onsite

About The Position

The QA Inspector is responsible for performing inspections of in-process product and ensuring appropriate documentation. This role assures cGMP compliance at all times on the production floor. The inspector will perform Quality Assurance tasks such as sampling, inspections, and tests to ensure manufactured products comply with internal SOPs, Safety initiatives, Company policies, FDA and DEA regulations. All work performed must be documented accurately and thoroughly. Management must be informed of any deviations from established standards or procedures. The inspector will also inspect and approve rooms, lines, and equipment prior to use, approve components for in-process operations, and monitor manufacturing and packaging areas for compliance. Review of records for cGMP compliance, accuracy, thoroughness, and good documentation practices is essential. The inspector will apply disposition status to components and in-process materials and issue QA Alerts for any questionable materials. Other duties assigned by the supervisor may also be required.

Requirements

Associate degree or equivalent work experience
1 - 3 years’ experience in quality control of a manufacturing environment
Bilingual (English and Spanish) required
Knowledge in cGMP regulations and FDA guidelines
Detailed oriented
Basic computer and math skills

Responsibilities

Performing the inspection of in-process product, and the appropriate documentation
Assuring cGMP compliance all at times in the production floor
Perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP's, Safety initiatives, Company policies, FDA and DEA regulations
Document all work performed, ensuring accuracy and thoroughness
Inform management of any deviations from established standards/procedures
Inspect and approve rooms, lines and equipment prior to use by manufacturing and R&D personnel
Approve components for in-process operations
Monitor manufacturing and packaging areas for compliance with internal SOPs, cGMPS and FDA/DEA regulations
Document all work activity in appropriate batch records, forms, and logs to ensure accuracy and compliance
Sample in-process items, and finished products
Perform required inspections and testing of in-process items and finished products
Process and distribute samples to different departments
Review records for cGMP compliance for accuracy and thoroughness and good documentation practices
Inform management of problems, failures and deviations from established internal and regulatory standards
Apply disposition status to components and in-process materials
Issue QA Alerts whenever any questionable component, in-process material or product is identified at any stage of production or storage