Quality Control Chemist (Indianapolis)

Contract 6 Months contract with a possibility of extension

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 regulations, procedures, and product specifications.

Key Responsibilities :

• Compendia experience (USP, EP, BP, JP, CP).
• Finished Product testing, Environmental Monitoring, 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 the successful on-time completion of required training curricula comprising 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 :