More jobs:
Quality Control Chemist
Job in
Columbia, Boone County, Missouri, 65201, USA
Listed on 2026-07-01
Listing for:
Kindeva Drug Delivery
Full Time
position Listed on 2026-07-01
Job specializations:
-
Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager, Regulatory Compliance Specialist
Job Description & How to Apply Below
Overview
At Kindeva we make products that save lives, ensuring better health and well‑being for patients around the world. Our work directly impacts patient care in a cGMP pharmaceutical environment.
Growth OpportunityOur St. Louis facility continues to grow, creating exciting opportunities for professional development and career advancement. Join us during this dynamic phase of growth and expand your expertise in analytical chemistry, GMP laboratory operations, investigation support, and pharmaceutical quality systems while contributing to life‑saving healthcare solutions.
Laboratory Operations & Testing- Perform and coordinate routine setup, calibration, operation, and maintenance of laboratory instruments and equipment.
- Analyze samples using a variety of analytical techniques and instrumentation in accordance with established procedures and specifications.
- Lead or coordinate testing schedules to support business priorities and timely completion of laboratory activities.
- Prepare solutions and standardize test solutions as defined by analytical methods or compendial requirements.
- Perform work in a timely and safe manner while complying with regulatory, company, and compendial requirements.
- Practice cGMP principles, including proper documentation, maintenance of records, archival of raw data, attention to specification limits, and immediate notification of any out‑of‑specification (OOS) results.
- Document and record analytical testing activities and data, ensuring reports are accurate, complete, and traceable to procedures, equipment, instruments, and reagents utilized.
- Demonstrate practical laboratory skills and a strong understanding of chemistry theories, analytical techniques, and quality procedures.
- Review and revise SOPs, analytical methods, and related laboratory documentation as required.
- Participate in routine calibration, verification, and maintenance activities for laboratory instrumentation.
- Identify, propose, and implement process and method improvements that enhance efficiency, robustness, compliance, and data quality.
- Support data collection, trend analysis, and peer review activities associated with process improvement opportunities.
- Collaborate closely with Manufacturing, Quality Assurance, Validation, Technical Services, and Process Transfer teams to address technical and operational challenges.
- Ensure compliance with Good Documentation Practices (GDP), data integrity requirements and cGMP expectations.
- Knowledge of compendial requirements including USP, EP, and other applicable references; cGMP guidelines; FDA regulations; laboratory safety procedures; SDS requirements; laboratory instrumentation; and inorganic and organic chemistry principles.
- Bachelor’s Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline with 0–3 years of laboratory experience or an equivalent combination of education and experience/training. Experience in a GMP‑regulated pharmaceutical, biotechnology, medical device, or other regulated laboratory environment is preferred.
- Ability to read and interpret compendial methods, SOPs, technical procedures, scientific literature, professional journals, and governmental regulations.
- Author scientific reports, business correspondence, and departmental procedures; perform mathematical calculations and basic statistical functions, including graphing and interpretation of data.
- Define problems, collect and analyze data, establish facts, and draw valid conclusions.
- Experience with analytical instrumentation and laboratory techniques such as HPLC, UPLC, GC, Dissolution, UV/Vis, FTIR, Karl Fischer, particle size analysis, or similar technologies is preferred.
- Knowledge of Windows‑based software applications such as Word, Excel, and Outlook; experience with chromatography data systems and data processing software, particularly Empower, is preferred.
- Ability to multitask across multiple priorities and responsibilities while maintaining attention to detail and compliance requirements.
- Ability to work effectively under strict production, quality, and…
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