Analytical Chemist II: GMP QC for Animal Health

Mission Statement: Our mission is the development and manufacturing of products that improve the lives of animals, while ensuring the safety, quality, and compliance of the products to the highest industry standards.

SUMMARY:

The Analytical Chemist II is responsible for performing chemical and physical testing of raw materials, in-process materials, finished products, stability samples, validation samples, and cleaning verification samples in support of Vetio Animal Health manufacturing operations. The position independently executes routine and non-routine laboratory testing using compendial and validated analytical methods while ensuring compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), applicable regulatory requirements, and internal procedures. The Analytical Chemist II serves as a technical resource within the laboratory by supporting method validation and transfer activities, laboratory investigations, stability programs, troubleshooting analytical methods and instrumentation, mentoring junior laboratory personnel, and participating in continuous improvement initiatives.

DUTIES AND RESPONSIBILITIES:

Perform analytical, physical, and chemical testing of raw materials, in-process materials, finished products, stability samples, validation samples, and other laboratory samples in accordance with approved procedures and specifications. Execute laboratory activities in compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), data integrity principles, regulatory requirements, and company procedures. Operate, maintain, troubleshoot, and support qualification activities for laboratory equipment and instrumentation used in quality control testing. Review, document, and report analytical results accurately and in a timely manner while ensuring compliance with established specifications and acceptance criteria. Participate in laboratory investigations, including out-of-specification (OOS), out-of-trend (OOT), deviations, and other quality events, supporting root cause analysis and corrective actions as required. Support method development, method verification, method transfer, method validation, and other laboratory projects through protocol writing, execution, data analysis, technical reporting, and implementation activities. Support stability programs, process validation activities, cleaning validation activities, and other product lifecycle initiatives as assigned. Maintain laboratory supplies, reagents, standards, reference materials, and controlled documentation to ensure uninterrupted laboratory operations. Assist in continuous improvement initiatives by identifying opportunities to enhance laboratory efficiency, compliance, data quality, and operational effectiveness. Provide technical support and collaboration to Quality Assurance, Manufacturing, Technical Services, Research and development, Supply Chain, and other departments as needed. Train, mentor, and provide technical guidance to laboratory personnel while supporting departmental goals,priorities, and workflow management. Support internal audits, customer audits, regulatory inspections, and other compliance activities as required. Maintain a safe, clean, and organized work environment in accordance with company safety policies and applicable regulatory requirements.

QUALIFICATIONS:

Education and Experience: Bachelor’s Degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related scientific discipline Minimum three (3) years of analytical laboratory experience in a GMP-regulated manufacturing environment Experience within pharmaceutical, veterinary pharmaceutical, nutraceutical, animal health, food supplement, or cosmetic manufacturing industries Experience with HPLC method development and validation Experience supporting FDA, customer, or third-party audits-Preferred Experience with stability programs and laboratory investigations-Preferred Technical Knowledge and Skills: Knowledge of applicable requirements including 21 CFR Part 211, 21 CFR Part 507, USP compendial requirements, and Data Integrity principles Strong understanding of analytical chemistry principles Working knowledge of USP compendial testing requirements Knowledge of cGMP requirements and laboratory compliance expectations Strong analytical and troubleshooting abilities Ability to perform calculations and data analysis Excellent organizational and time-management skills Ability to prioritize multiple projects simultaneously Computer skills: Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams) SharePoint ERP Systems (SAP)-Preferred Electronic Quality Management Systems (eQMS)-Preferred Other skills required: Read, Write, Comprehend SOP, Technical documents in English Understanding of OSHA regulations Understanding of standard operating procedures (SOPs) and work instructions Ability to read and interpret technical documents, (SOPs, Batch records) Knowledge of safety protocols and PPE usage #J-18808-Ljbffr Vetio Animal Health (US)