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We are seeking a highly motivated and detail-oriented QC Chemist to join our dynamic team in Indianapolis, IN. The ideal candidate will perform routine and non-routine testing of raw materials, in-process materials, and finished products to ensure that they meet the required specifications for quality, safety, and regulatory compliance. This role is critical to maintaining the integrity of our products and ensuring compliance with industry standards.

As a QC Chemist, you will work in a fast-paced environment, using a variety of analytical techniques and instrumentation to support manufacturing operations, troubleshoot potential issues, and contribute to continuous improvement in our laboratory practices.

Key Responsibilities

Perform Routine Testing: Conduct routine testing on raw materials, intermediates, and finished products according to established procedures and specifications, using analytical methods such as pH, titrations, and viscosity analysis.

Sample Management: Receive, log, and manage samples in compliance with laboratory protocols. Ensure proper documentation and labeling for each sample, ensuring integrity and traceability throughout testing processes.

Data Collection & Analysis: Record test results in laboratory notebooks and LIMS (Laboratory Information Management System). Analyze data for trends, consistency, and compliance with established specifications. Ensure data integrity and report deviations or out-of-specification (OOS) results promptly.

Documentation & Reporting: Maintain accurate and detailed records of all testing activities and results. Prepare test reports, batch records, and certificates of analysis (COA) as needed. Ensure all documentation is compliant with GMP, GLP, and regulatory standards.

Quality Assurance Support: Assist in the identification of non-conformance issues, out-of-specification results, and deviations. Participate in investigations to determine root causes and corrective actions. Provide support during audits by internal and external regulatory bodies.

Safety and Compliance: Adhere to laboratory safety guidelines and practices, including proper handling of chemicals and hazardous materials. Ensure compliance with all federal, state, and local regulations, including OSHA and EPA standards.

Maintain Laboratory Environment: Ensure the laboratory is clean, organized, and in compliance with regulatory requirements. Assist in inventory management of chemicals, reagents, and lab supplies, ensuring stock levels are sufficient and within expiration dates.

Team Collaboration: Work closely with other members of the QC team and Manufacturing to ensure smooth operations and resolve issues as they arise. Participate in cross-functional teams as needed.

Continuous Improvement: Participate in ongoing training and development programs to stay up-to-date with the latest analytical techniques, industry standards, and regulatory requirements. Provide suggestions for process improvements in the laboratory.

Qualifications

Education:

A Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field is required.Additional certifications or training in GMP, GLP, or laboratory safety is a plus.

Experience:

0-3 years of hands-on experience in a quality control laboratory or related laboratory environment, preferably in the pharmaceutical, biotechnology, or manufacturing industries.Experience in using laboratory instruments such as HPLC, GC, UV-VIS, FTIR, and pH meters is strongly preferred.Experience with LIMS (Laboratory Information Management Systems) or similar data management software is a plus.

Technical Skills:

Proficiency in analytical chemistry techniques and laboratory equipment operation and troubleshooting.Strong knowledge of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) principles and their application in a laboratory setting.Familiarity with regulatory standards such as USP, ICH, and FDA regulations.

Attention to Detail:

Strong attention to detail, with the ability to accurately record and analyze data, and identify deviations from established specifications.

Problem-Solving Skills:

Ability to troubleshoot and resolve issues related to equipment and testing procedures efficiently.

Communication Skills:

Strong verbal and written communication skills. Ability to effectively document and communicate findings to colleagues, supervisors, and management.

Physical Requirements:

Ability to lift and carry laboratory equipment and materials (up to 25 pounds).Ability to stand for extended periods and perform tasks in a laboratory setting.Work Environment and ConditionsLocation: The position is based in our Indianapolis, IN facility.Work Schedule: This is a full-time position, with typical laboratory hours. Some overtime or weekend shifts may be required depending on the workload and project deadlines.Safety Considerations: Work will be performed in a laboratory environment, requiring the use of personal protective equipment (PPE), such as lab coats, gloves, safety goggles, and face shields.Why Join Us?Competitive Salary and Benefits: We offer a competitive salary along with health insurance, paid time off, and other benefits.Professional Development: Opportunities for training and career advancement within the organization.Collaborative Environment: Join a passionate team dedicated to excellence in quality control, innovation, and customer satisfaction.

If you are a self-motivated individual with a passion for quality and attention to detail, we encourage you to apply for this exciting opportunity to contribute to our company's success and the development of high-quality products.

To Apply: Please submit your resume and cover letter detailing your relevant experience and interest in the position.

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