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
Job Specifications and Qualifications:
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.
