Quality Systems Specialist

Actalent; La Verne (CA); On-site; USD 76,000 - 90,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) plan

Life Insurance

Disability insurance

HSA

Transportation benefits

Employee Assistance Program

Paid time off

Job summary

Actalent is seeking a Quality Systems Specialist to manage QC instrumentation, including IOPQ, calibration, and maintenance in a La Verne, CA laboratory environment.

The role involves troubleshooting, protocol development, and ensuring compliance with GMPs, ALCOA, and data integrity standards. Collaboration across cross-functional teams and involvement in CAPA implementations are essential.

Qualifications

• Requires BS or MS with related experience in pharma/biotech.
• Experience in QC instrumentation, IOPQ, calibration, and maintenance.
• Familiarity with GMPs, ALCOA, and data integrity regulations.

Responsibilities

• Manage QC Instrumentation including IOPQ, maintenance, and calibration.
• Coordinate with service providers for equipment upkeep.
• Develop and revise procedures and validation scripts for lab equipment.
• Support data review, investigations, and CAPA implementations.
• Populate quality metrics and assist cross-functional teams on projects.

Skills

GMPs & ALCOA

Data Integrity

Laboratory troubleshooting

QA review of data

Education

BS degree

MS degree

Tools

Empower

LIMS

Quality management software

HPLC/UPLC

UV

Endotoxin chromogenic (LAL)

Job description

Job Title: Quality Systems Specialist

Job Description

We are seeking a dedicated Quality Systems Specialist who will primarily manage QC Instrumentation including Installation, Operation, and Performance Qualification (IOPQ). This role involves routine maintenance, repair, and calibration/re-calibration of equipment, as well as qualification maintenance. You will work closely with service providers, troubleshoot issues, and generate protocols and reports. Additionally, you will support technical review of data, laboratory investigations, and CAPA implementations.

Responsibilities

• Manage QC Instrumentation including 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 to 4+ years of relevant experience and a BS degree, or 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.

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.

Job Type & Location

This is a Contract position based out of La Verne, CA.

Pay And Benefits

The pay range for this position is $55.00 - $65.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 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 This is a fully onsite position in La Verne,CA. Application Deadline This position is anticipated to close on Oct 6, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance our engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.