Quality Systems Specialist

Responsibilities

• Manage QC instrumentation including Installation, Operation, and Performance Qualification (IOPQ), routine maintenance, and calibration.
• Schedule and liaise with service providers.
• Conduct general troubleshooting and validation test scripts for lab equipment.
• Generate and revise procedures and reports.
• Support technical review of data from instrument qualifications, repairs, and maintenance.
• Participate in laboratory investigations and CAPA implementations.
• Populate quality metrics as necessary.
• Develop procedural and validation lifecycle documents for QC analytical instrumentation.
• Engage in validation and commercial/developmental manufacturing activities.
• Collaborate on cross‑functional projects as a team member.

Essential Skills

• 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.

Additional Skills & Qualifications

• 3–4+ years of relevant experience and a BS degree, or 2+ years of relevant experience and an 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.

Work Environment

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.

Pay

Pay range for this position is $55.00 – $65.00 per hour. Individual compensation within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job‑related factors.

Benefits

• Medical, dental & vision coverage
• Critical Illness, Accident, and Hospital coverage
• 401(k) retirement plan – pre‑tax and Roth post‑tax contributions available
• Life insurance (voluntary life & AD&D for the employee and dependents)
• Short‑ and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time off/leave (PTO, vacation, or sick leave)

Workplace Type

Fully onsite position in La Verne, CA.

Application Deadline

Anticipated close date: September 26, 2026.