QC Chemist / Raw Material testing/ QC inspector

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
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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.

• Perform laboratory analytical testing and documentation
• Perform analytical testing on plant production samples
• Perform wet chemistry tests on samples
• Performing analytical test method validation activities for quality control methods
• Participate in troubleshooting of analytical test methods and laboratory instruments
• Conduct experiments using wet chemistry
• Perform testing to support analytical method development, validation and routine testing including stability testing
• Support analytical method development, validation, and routine testing including stability testing
• Assist in analytical method development/validation/transfer
• Perform routine analytical testing on raw materials, finished goods, stability and other samples
• Running laboratory analysis on raw materials, in-process samples and final products
• Develop analytical methods for new ingredients
• Perform analysis of raw materials, in-process and finished products using analytical instruments and established analytical procedures and techniques
• Collect samples, prepare chemical reagents and analytical standards
• Perform physical and chemical testing of bulk, finished product and stability samples using laboratory test procedures
• Perform routine laboratory analysis, such as finished product testing, dissolution testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing
• Conduct routine laboratory analyzes such as finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing
• Developing and documenting analytical methods
• Operate analytical instrumentation such as HPLC, UV, FTIR
• Operate, and maintains laboratory analytical equipment