What are the responsibilities and job description for the Pharmaceutical Quality Control Chemist position at Shoolin Inc?
Job Title: Senior QC Chemist
Location: Portage, IN (Onsite)
Must Have:
- 5 years of Pharmaceutical Quality Control (QC) experience
- Strong hands-on experience with HPLC, GC, Dissolution, FTIR, Wet Chemistry
- Experience testing Raw Materials, In-Process, Finished Products, Stability & Validation Samples
- Strong understanding of cGMP, GDP, GLP and regulated pharmaceutical environments
- Experience with OOS, Deviations, CAPA Investigations
- Experience reviewing analytical data, chromatograms, and GMP documentation
- Hands-on experience with Chromeleon or similar chromatography software
- Experience with Method Transfer and analytical method validation
- Ability to troubleshoot and maintain analytical instruments
- Technical writing experience (SOPs, Protocols, Reports, Specifications)
- Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related discipline
Key Responsibilities:
- Perform QC testing using HPLC, GC, FTIR, Dissolution, and other analytical techniques
- Review, approve, and release analytical results
- Prepare reagents, standards, and laboratory solutions
- Review chromatographic data and GMP documentation
- Support OOS, CAPA, Deviation, and Complaint Investigations
- Execute method transfers and support validation activities
- Author/review SOPs, protocols, specifications, and reports
- Calibrate, maintain, and troubleshoot analytical instruments
- Coordinate sample management, inventory, and laboratory operations
- Support audits, continuous improvement initiatives, and cross-functional projects
- Train and mentor junior QC staff