QA Inspector

QA Inspector
SRG4 offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

• Location: Kendall, Florida
• Industry: Pharmaceutical
• Hours: Monday-Thursday, 2nd shift, 3:30pm-2:00am
• Salary: $20/hr. with 10% shift differential
• Employment Type: Contract with the opportunity to go permanently based on performance and business needs.

Environment: Our client is a dynamic specialty pharmaceutical company engaged in the research, development, manufacture, marketing, and sale of prescription pharmaceutical products. They are a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products.

Overview
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.

Responsibilities

• Inspect and approve rooms, lines and equipment prior to use by manufacturing and R&D personnel.
• Approve components for in-process operations.
• Monitor manufacturing 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.
• Inform management of problems, failures and deviations from established internal and regulatory standards.
• Apply disposition sticker 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.
• Perform swab and Rodac Plate sampling as required.
• Perform transactions in JD Edwards when required.

Qualifications

• High school diploma or equivalent. Basic computer skills required. Basic math skills required (i.e., calculating %, addition, subtraction, multiplication, division). Ability to read, write, communicate and follow instructions (verbal and written) in English is required.
• JD Edwards experience preferred, but not required
• Minimum 1-2 years within an FDA/cGMP environment inspecting products

Keywords: inspections, inspector, quality, QA, batch records review, manufacturing, production, documentation, in-process, sampling, cGMP, GMP, FDA, pharmaceuticals, finished products

EOE/ADA