QC Chemist

4 weeks ago

Indianapolis, United States Abacus Full time

Description: Job Title: QC Chemist (Raw Material) Location: Onsite/Indianapolis, IN Sift timings: 1st Shift Thursday-Sunday (8 am to 6 pm) eventually Wednesday to Saturday (1 Position) Job Description: The QC Chemist will support all technical aspects related to quality control testing readiness, including QC reagents and materials management, equipment preparation and daily cleaning and maintenance activities, sample management and QC testing, and documentation completion and review in full compliance with GMP regulation, procedures, and product specifications Key Responsibilities: Compendia experience (USP, EP, BP, JP, CP) Finished Product testing, Environmental Monitoring and Sterility QC testing, and reporting of the QC results. Escalation in case of non-conformances and deviations and manage these quality incidents as per procedures. Support deviation investigations, OOS/OOT/OOE investigations, CAPA follow up and implementation, and Change Control management, including procedure and form revisions. Participation in assigned qualification/validation activities, as necessary. Responsible for successful on time completion of required training curricula comprising of the necessary Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications, Testing and specifications, and other relevant training including HSE for the specific role. Prepares applicable documents, forms, and records such as analytical batch records and follows Good Documentation Practices. Support internal and external Audits and Inspections, as required. Essential Requirements: Education: Bachelors' degree required in relevant Scientific discipline (e.g Chemistry, Microbiology). Minimum of 2-3-year experience in cGMP or aseptic environment required. Knowledge of cGMP regulations and FDA guidance applicable to Quality Control for product and Environmental Monitoring testing, as well as Aseptic techniques. Practical experience with Microbiology method verification and routine testing practices, EM Monitoring and basic knowledge of method/equipment validation principle and methodologies preferred HPLC knowledge is required. bility to interpret analytical data and convert into technical documentation. Basic knowledge and understanding of aseptic principles and techniques Quality Control Sampling Quality Control (QC Testing) General HSE knowledge Client Compensation and Benefit. Please make sure you communicate with the worker before you submit on this role that the use of radioactive testing for its Chemist contractors at the RLT Indianapolis site. We do everything we can to keep our people safe and constantly check to determine if contamination occurs. We have waste streams setup to remove contaminated objects from the lab. We also have dosimeters that the employees wear as well as dosimeter rings and dosimeters throughout the facility to confirm any potential contamination. Enable Skills-Based Hiring No Supplier FLSA Classification Non-exempt USA OSHA Information (No Value) Hours per Day 10 Hours per Week 40 Total Hours 2,050.00

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