Pharma QA Auditor – HPLC & cGMP Specialist (2nd Shift)

Missouri Analytical Laboratories, Inc.; Indiana (PA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Excellent benefits

Job summary

Missouri Analytical Labs is a pharma testing laboratory in downtown St. Louis seeking a qualified candidate for 2nd shift (3:30 PM–midnight, Sun–Thu) on a permanent full-time basis.

The role focuses on QA with emphasis on HPLC data review, cGMP compliance, and collaboration with chemists and microbiologists. Responsibilities include data review, calculations, chromatography review, notebook audits, instrument calibrations, OOS investigations, SOP writing, IQ/OQ/PQ, and training in a GMP

Qualifications

• Knowledge of cGMP
• Familiarity with HPLC, UV-Vis, GC, AA
• Familiarity with Waters Empower software
• Familiarity with microbiology testing
• Attention to detail
• Good level of math & statistical skills
• Ability to work with chemists & microbiologists to resolve data issues
• Experience in equipment trouble-shooting a plus
• Tracking and distribution of standards and samples to QC chemists

Responsibilities

• Review laboratory data for accuracy & completeness
• Check calculations
• Review chromatography (HPLC) data
• Review notebook entries
• Communicate need for corrections to chemists & microbiologists
• Review instrument calibrations
• Participate in OOS investigations
• Writing of SOPs
• IQ/OQ/PQ
• Training
• Internal/External audits

Skills

Attention to detail

Math & statistics

Data review & collaboration

Equipment troubleshooting

Tools

HPLC

UV-Vis

GC

AA

Waters Empower software

Job description

Missouri Analytical Labs is a pharma testing laboratory in downtown St. Louis seeking a qualified candidate for 2nd shift (3:30 PM–midnight, Sun–Thu) on a permanent full-time basis.

The role focuses on QA with emphasis on HPLC data review, cGMP compliance, and collaboration with chemists and microbiologists. Responsibilities include data review, calculations, chromatography review, notebook audits, instrument calibrations, OOS investigations, SOP writing, IQ/OQ/PQ, and training in a GMP