Quality Assurance Inspector II

Amneal Pharmaceuticals; Branchburg Township (NJ); On-site; USD 40,000 - 70,000; Full time

Job summary

An established industry player in pharmaceuticals is seeking a dedicated Quality Assurance Inspector II. In this role, you will ensure that all incoming materials and packaging components meet stringent quality standards. Your responsibilities will include conducting inspections, sampling, and testing, as well as overseeing the entire manufacturing process to guarantee compliance. This is a full-time position that offers an exciting opportunity to contribute to the quality assurance team in a dynamic environment, where your attention to detail and organizational skills will be essential for success.

Qualifications

• At least 2 years of experience in Quality Assurance or related fields.
• Ability to conduct inspections and sampling of materials.

Responsibilities

• Monitor and ensure compliance of raw materials and packaging components.
• Conduct inspections and maintain detailed records of activities.

Skills

Organizational Skills

Basic Computer Skills

Attention to Detail

Education

High School diploma or GED

Tools

Word

Excel

Job description

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Description: To monitor and ensure all incoming raw materials, packaging components, and returned goods are sampled, inspected, and tested (where applicable) for compliance with established specifications. To oversee all phases of drug manufacturing to ensure compliance with specifications. To receive, inspect, release, and control labels and outserts. To ensure quality compliance throughout the packaging process.

Job Description: To monitor and ensure all incoming raw materials, packaging components, and returned goods are sampled, inspected, and tested (where applicable) for compliance with specifications. To oversee manufacturing phases for compliance. To manage labels and outserts, ensuring quality standards are met before, during, and after packaging.

Essential Functions:

• Perform inspections, sampling, and testing of raw materials, packaging components, and returned goods following detailed procedures. Prepare samples for chemical and microbiological analysis and deliver to QC. Use measuring devices like scales and micrometers to verify conformance. Maintain detailed records of activities. Verify expiry and retest dates using vendor and in-house COA. Collect samples for stability testing. Conduct room, equipment, and line checks. Perform in-process testing. Prepare samples for QC and QA. Maintain standard weights for balance verification. Conduct labeling component inspections and manage inventory. Ensure proper labeling and packaging reconciliation. Maintain warehouse areas and monitor environmental conditions.
• Review engineering records, batch records, and equipment functionality during manufacturing. Maintain retention samples and monitor environmental conditions in sample rooms.

Additional Responsibilities:

• Disposal of rejected materials and returned products as per SOP. Conduct environmental monitoring. Prepare reports for customer complaints. Perform other duties as assigned.

Qualifications:

• High School diploma or GED required.
• At least 2 years of experience in QA or related fields.

Skills:

• High energy and organizational skills. Creativity and flexibility. Basic computer skills (Word and Excel).

Knowledge:

• Good math skills and attention to detail. Record observations for process improvements.

Additional Info:

• Entry-level position. Full-time employment in Quality Assurance within Pharmaceutical Manufacturing.