QA Inspector
The Staffing Resource Group, Inc
- Miami, Florida, United States
- Miami, Florida, United States
À propos
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 SOPs, safety initiatives, company policies, FDA and DEA regulations. Document all work performed, ensuring accuracy and thoroughness. Inform management of any deviations from established standards or 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
IND123
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Compétences linguistiques
- English
Avis aux utilisateurs
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