Intellectt Inc
Quality Assurance Specialist #Pharmaceutical
Intellectt Inc, Oklahoma City, Oklahoma, United States
Quality Assurance Specialist
We are seeking a detail-oriented Visual Inspection Operator for a 6 to 12‑month contract role in our Fill‑Finish and Packaging operations based in New York, NY. The successful candidate will be responsible for conducting manual and/or automated visual inspection of sterile products to ensure compliance with GMP, FDA, and internal quality standards. This role is critical to ensuring only defect‑free products reach our patients.
Contract 6–12 Months
Base pay range $30.00/hr – $45.00/hr
Key Responsibilities
Conduct 100% manual or semi‑automated visual inspection of sterile pharmaceutical products (e.g., vials, syringes, ampoules).
Detect and categorize defects such as particulate matter, container integrity issues, cosmetic imperfections, and fill‑level anomalies.
Operate inspection equipment and tools (e.g., magnifiers, lighting booths, inspection conveyors).
Accurately document inspection results in batch records or electronic systems (e.g., MES).
Handle rejected units according to SOPs and non‑conformance procedures.
Follow cGMP, FDA, and company quality standards during all operations.
Participate in cleaning, line clearance, and equipment setup/changeover activities.
Work closely with QA and Production teams to address quality issues.
Maintain aseptic practices and follow cleanroom gowning protocols.
Support investigations and implementation of corrective actions when required.
Perform other duties as assigned to support manufacturing and inspection goals.
Qualifications
Minimum 3‑5 years of relevant experience in pharmaceutical visual inspection, fill‑finish, or packaging within a cGMP‑regulated environment.
Strong attention to detail and good manual dexterity.
Excellent visual acuity (must pass visual and color vision test).
Familiarity with SOPs, batch records, and GMP documentation.
Ability to work in a sterile/cleanroom environment and follow aseptic techniques.
Must be comfortable performing repetitive tasks while maintaining accuracy.
Seniority level Associate
Employment type Contract
Job function Quality Assurance
Industries Pharmaceutical Manufacturing, Medical Equipment Manufacturing
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Contract 6–12 Months
Base pay range $30.00/hr – $45.00/hr
Key Responsibilities
Conduct 100% manual or semi‑automated visual inspection of sterile pharmaceutical products (e.g., vials, syringes, ampoules).
Detect and categorize defects such as particulate matter, container integrity issues, cosmetic imperfections, and fill‑level anomalies.
Operate inspection equipment and tools (e.g., magnifiers, lighting booths, inspection conveyors).
Accurately document inspection results in batch records or electronic systems (e.g., MES).
Handle rejected units according to SOPs and non‑conformance procedures.
Follow cGMP, FDA, and company quality standards during all operations.
Participate in cleaning, line clearance, and equipment setup/changeover activities.
Work closely with QA and Production teams to address quality issues.
Maintain aseptic practices and follow cleanroom gowning protocols.
Support investigations and implementation of corrective actions when required.
Perform other duties as assigned to support manufacturing and inspection goals.
Qualifications
Minimum 3‑5 years of relevant experience in pharmaceutical visual inspection, fill‑finish, or packaging within a cGMP‑regulated environment.
Strong attention to detail and good manual dexterity.
Excellent visual acuity (must pass visual and color vision test).
Familiarity with SOPs, batch records, and GMP documentation.
Ability to work in a sterile/cleanroom environment and follow aseptic techniques.
Must be comfortable performing repetitive tasks while maintaining accuracy.
Seniority level Associate
Employment type Contract
Job function Quality Assurance
Industries Pharmaceutical Manufacturing, Medical Equipment Manufacturing
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