Lab Technician/ QC chemist/ Downstream Purification Technician/ Analytical Chemi

Position Title: QC Chemist (Raw Material) Work Location: Indianapolis, IN 46241 Assignment Duration: 12 months Work Schedule: 1st Shift Thursday–Sunday (8 am–6 pm) eventually Wednesday–Saturday Work Arrangement: 100% Onsite Position Summary: • 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 Qualification & Experience : • 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 • Ability to interpret analytical data and convert into technical documentation • Basic knowledge and understanding of aseptic principles and techniques Applicant Notices & Disclaimers For information on benefits, equal opportunity employment, and location-specific applicant notices, click here At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $40.00/hr. Verifying that product quality attributes Implementing changes to the quality system Ensure sound quality decisions are made Identify ways to provide quality control and quality assurance through the inspection and reporting process Ensure accuracy and completeness of quality review Adhere to the laboratory's quality control policies Adhere to all requirements of established quality systems Ensure awareness of quality issues on the project Perform quality check on manufacturing shop drawings Provide quality inspections on all related items Develop and implement quality systems and procedures Perform quality check on metal fabrication documents Assist in quality audits and perform corrective actions Maintain high standards for quality work and responsiveness Assist in coordinating external vendor and subcontractor quality audits Take the initiative to improve the quality of operations and to improve and maintain a quality culture with a goal of consistency Take the initiative to improve the quality of operations and to improve and maintain a quality culture Conducting and forming corrective action plans for internal quality audits, customer quality audits and regulatory inspections Assist quality, engineering and production personnel with investigations of part defects or any quality related issues Review quality data and make proposals for continuous improvement