Quality Control Chemist (Indianapolis)

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 : 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 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.