Quality Assurance Raw Material Specialist

Zoetis•Lincoln, NE

About The Position

The Quality Assurance Raw Material Specialist is responsible for overseeing the quality control and release of raw materials used in pharmaceutical and biological production. This role ensures that all incoming raw materials comply with regulatory requirements, company standards, and product specifications. The specialist will collaborate with various departments, including procurement, manufacturing, regulatory affairs, and quality control to maintain the highest standards of material quality. Hours: 1st shift.

Requirements

Bachelor’s degree in Chemistry, Pharmacy, or related field.
Minimum of 3-5 years of experience in pharmaceutical/biological manufacturing or quality assurance/control.
In-depth knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory requirements (FDA, EMA, USDA etc.).
Strong understanding of risk management principles and CAPA processes.
Excellent communication and interpersonal skills for effective collaboration with cross-functional teams.
Experience working within a GMP regulated Biotech or Pharmaceutical industry.
Detail-oriented with strong organizational skills.
Problem-solving and critical thinking ability.
Ability to work under pressure and manage multiple priorities.
Commitment to quality and continuous improvement.
Ability to make independent decisions based off industry and regulations knowledge.
Demonstrated ability to write and review technical documents with high attention to detail.
High integrity and self-motivation

Nice To Haves

Experience with raw material testing, including wet chemistry and analytical methods such as HPLC, GC, and FTIR, is a plus.
Proficiency in quality management systems (QMS) e.g., ETS, Veeva Vault, LIMS, and enterprise resource planning (ERP) software i.e., SAP.
Experience with MS Word, Excel, Outlook, and Teams

Responsibilities

Raw Material Inspection & Testing: Perform maintenance activities on specifications, sampling requirements, and documentation of incoming raw materials to ensure they meet established procedures and quality standards. Coordinate with warehouse personnel for the sampling of raw material and laboratory personnel for testing raw materials according to predefined specifications and standard operating procedures (SOPs). Review and approve laboratory test results and reports for material acceptance or rejection.
Supplier Management: Collaborate with the procurement team to qualify new suppliers and supplier changes. Conduct evaluations of supplier documentation to ensure consistent raw material quality and compliance within regulatory guidelines. Address quality-related issues with suppliers through investigation of material nonconformances.
Material Release: Ensure the timely release of raw materials for production by verifying that all quality requirements have been met, including documentation review and approval. Maintain proper documentation and records of raw material inspections, test results, and release status in compliance with Good Manufacturing Practices (GMP).
Documentation and Compliance: Maintain accurate records for raw materials, including certificates of analysis (COAs), specifications, and any deviations or non-conformances. Ensure compliance with relevant regulatory agencies (e.g., FDA, EMA, USDA) and internal quality systems, including GMP, Zoetis Quality Standards, and Zoetis Global Procedures. Support internal and external audits by providing necessary documentation and evidence of quality processes.
Continuous Improvement: Identify opportunities for process improvements in raw material handling, testing, and release procedures. Participate in cross-functional meetings to address quality concerns and propose solutions for improving the overall quality system. Provide training to team members on best practices related to raw material quality control and regulatory requirements.
Risk Management & Investigations: Investigate raw material quality deviations or non-conformances, determining root causes to support suppliers’ investigations and agree to corrective and preventive actions (CAPAs). Assist in risk assessments related to raw material quality and ensure appropriate controls are in place to mitigate identified risks.