Pharma Materials Quality Inspector | cGMP & GDP

Nephron Pharmaceuticals Corporation; Columbia (SC); Hybrid; USD 70,000 - 95,000; Full time

Job summary

Nephron Pharmaceuticals Corporation is seeking a Quality Operations Materials Management Specialist to perform inspection, sampling, and disposition of raw materials, production components, and resin. The role collaborates with other departments to ensure timely and compliant receipt, sampling, and releases.

The ideal candidate has experience with GDP/ALCOA++, LIMS, inventory systems, and cGMP, with strong attention to documentation, accuracy, and ability to work independently or in a team in a

Qualifications

• High school diploma or GED is required.
• Minimum of 2 years of related experience in the pharmaceutical industry preferred.
• ISO Cleanroom experience (ISO-8/7/5) preferred.

Responsibilities

• Perform incoming inspection on raw materials, production components, and resin.
• Adhere to ALCOA++ principles for GDP.
• Review shipping and manufacturer/supplier documentation to ensure information is accurate.
• Collect samples using the AQL Inspector’s Rule that conforms to ANSI/ASQ Z1.4 and MIL-STD 105E standards.
• Use LabVantage Information Management Systems (LIMS) to create batches, collect/submit samples, disposition batches, and generate a Certificate of Analysis (COA).
• Use the inventory management system to receive (as required), disposition, determine retest, document adjustments, and monitor expiry of items.
• Determine disposition based on comparison of results from inspection and/or testing to specification.
• Collect and submit samples to Quality Control Microbiology and Analytical Services departments as required for laboratory testing.
• Perform quality verification/review of company documents as required.
• Follow procedures to ensure Current Good Manufacturing Practices (cGMP) are satisfied.
• Pass required medical screenings to ensure safe handling of pharmaceutical raw materials used within the manufacturing process and participate in any periodic medical screenings as defined by the company.
• Perform other duties and responsibilities as evident or required

Skills

ALCOA++ GDP

Inventory management

MS Word

MS Excel

Communication

cGMP knowledge

Teamwork

Discretion

Prioritization

Independent work

Education

High school diploma or GED

ISO cleanroom experience (ISO-8/7/5)

Job description

Nephron Pharmaceuticals Corporation is seeking a Quality Operations Materials Management Specialist to perform inspection, sampling, and disposition of raw materials, production components, and resin. The role collaborates with other departments to ensure timely and compliant receipt, sampling, and releases.

The ideal candidate has experience with GDP/ALCOA++, LIMS, inventory systems, and cGMP, with strong attention to documentation, accuracy, and ability to work independently or in a team in a