Quality Control Chemist I

Kindeva Drug Delivery•Bridgeton, MO

1d•Onsite

About The Position

Transform Lives Through Innovation Join a rapidly expanding pharmaceutical CDMO where your work directly impacts patient health outcomes worldwide. Kindeva offers a rewarding and fast-paced cGMP pharmaceutical environment where your work directly contributes to the safety, quality, and efficacy of life-saving drug products. As a Chemist I, you will perform routine and non-routine quality control testing of raw materials, in-process materials, finished products, and stability samples, contribute to investigations and continuous improvement initiatives, and develop your analytical skills alongside a dedicated and collaborative team. Our 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.

Requirements

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.
Ability to read and interpret compendial methods, SOPs, technical procedures, scientific literature, professional journals, and governmental regulations.
Ability to author scientific reports, business correspondence, and departmental procedures
Ability to perform mathematical calculations using whole numbers, fractions, decimals, and basic statistical functions, including graphing and interpretation of data.
Ability to define problems, collect and analyze data, establish facts, and draw valid conclusions.
Must have the ability to multitask across multiple priorities and responsibilities while maintaining attention to detail and compliance requirements.
Must have the ability to work effectively under strict production, quality, and performance deadlines.
Must be willing and able to support business needs outside of standard work hours when required, including occasional evenings, weekends, and holidays.
Employee is required to regularly use hands in order to handle materials and supplies
Employee is required to use computers for an extended period each day
Employee is required to effectively use electronic communication
Employee is required to regularly stand and walk for extended periods of time
Employee must occasionally lift and/or move up to 20 pounds
Ability to use proper PPE and be conscious of the work area hazards
Employee is required to follow all site safety procedures

Nice To Haves

Experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or other regulated laboratory environment is preferred.
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.
Experience with SDS-PAGE, Western Blot, icIEF, Plate Reader, ELISA, and large molecule testing is preferred.
Recent graduates with relevant internship, co-op, undergraduate research, or academic laboratory experience are encouraged to apply.

Responsibilities

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.
Perform routine setup, calibration, operation, and maintenance of laboratory instruments and equipment.
Analyze samples in accordance with established departmental, site, and corporate procedures, specifications, and policies.
Prepare solutions and standardize test solutions as defined by analytical methods or compendial requirements.
Perform assigned work in a timely and safe manner while complying with regulatory, company, and compendial requirements.
Practice cGMP principles, including proper laboratory 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.