Working knowledge of current Good Manufacturing Practices (GMPs), ALCOA principles, and pharmaceutical industry regulatory requirements.
Experience in Microbiology and/or Chemistry techniques such as gram staining, microbial identification, and complex chromatographic analyses.
Understanding of laboratory analytical instrumentation IOPQ, validation, maintenance, and troubleshooting.
Strong knowledge of regulatory requirements surrounding Data Integrity.
Familiarity with Quality Control and Quality Management Systems.
3 to 4+ years of relevant experience and a BS degree
2+ years of relevant experience and a MS degree
Prior experience in the pharmaceutical industry.
Experience with controlled document management, change management, and procedure updates.
Proficiency in laboratory systems such as HPLC/UPLC, UV, and endotoxin kinetic chromogenic methodology (LAL).
Experience with laboratory computerized systems like Empower, LIMS, and quality management software.
Proficiency in Microsoft Office applications.
The position requires working in a laboratory environment where adherence to GMPs and safety protocols is paramount.
The role is detail-oriented and demands a high level of organization and problem-solving skills.
The candidate should be comfortable working independently and possess strong communication skills to articulate team needs effectively.
The work environment is dynamic and requires a motivated individual with a strong sense of urgency.