Quality Operations Materials Management Specialist

Nephron Pharmaceuticals Corporation; West Columbia (SC); Presencial; USD 45.000 - 62.000; Jornada completa

Descripción de la vacante

Nephron Pharmaceuticals Corporation seeks a Quality Operations Materials Management Specialist to perform incoming inspections, sampling, and disposition for raw materials, components, and resin. The role requires strict adherence to ALCOA++ GDP principles and close collaboration across departments to ensure timely releases and accurate documentation.

The candidate should have at least 2 years in pharma, familiarity with LIMS (LabVantage), and cleanroom experience (ISO-8/7/5 preferred).

Formación

• High school diploma or GED required.
• Minimum of 2 years of related experience in the pharmaceutical industry preferred.
• ISO-8, ISO-7, and/or ISO-5 cleanroom experience preferred.

Responsabilidades

• Perform incoming inspection on raw materials, production components, and resin.
• Adhere to ALCOA++ principles for GDP and ensure documentation accuracy.
• Review shipping docs to ensure information correctness and traceability.
• Use LabVantage LIMS to create batches, collect samples, and generate COAs.

Conocimientos

Inventory management

ALCOA++ GDP

Microsoft Word

Microsoft Excel

Educación

High school diploma or GED

Herramientas

LabVantage LIMS

Inventory management system

Descripción del empleo

Job Purpose

The Quality Operations Materials Management Specialist is responsible for performing the full range of inspection, sampling, and disposition activities for specified raw materials, production components, and resin. Specialists work with other departments to ensure receipt, sampling, and releases are compliant and completed in a timely manner. Specialists perform these activities independently once trained and qualified.

Essential Duties And Responsibilities

• Perform incoming inspection on raw materials, production components, and resin.
• Adhere to ALCOA++ principles for Good Documentation Practices (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

Knowledge & Skills

• Competent in Microsoft Word and Excel.
• Experience with inventory management.
• Knowledge of ALCOA++ principles and GDP.
• Effective communication within the department and among departments.
• Professional integrity to ensure appropriate disposition of items sampled/inspected.
• Strong understanding of pharmaceutical industry best practices and cGMP.
• Ability to prioritize tasks and meet deadlines.
• Discretion in handling sensitive and confidential information.
• Ability to redirect when needed to meet business demands.
• Ability to work independently and as part of a team as necessary.

Education/Experience

• High school diploma or GED required.
• Minimum of 2 years of related experience in the pharmaceutical industry preferred.
• ISO-8, ISO-7, and/or ISO-5 cleanroom experience preferred.

Working Conditions & Physical Requirements

• Position requires sitting, standing, bending, walking throughout facility, and lifting (up to 40 lbs.).
• Position requires visual acuity screening.
• Position requires cleanroom gown certification.
• Position requires TB testing and health screen.
• Position may require use of NIOSH certified respirator, which requires medical evaluation.