Job Description
We are seeking a dedicated Quality Technician to maintain and enhance our validation and calibration programs within an aseptic filling facility. This role involves coordinating, performing, and scheduling requalifications and periodic reviews, as well as developing and documenting qualification and validation protocols and reports. The ideal candidate will conduct various testing procedures, implement document changes, and assist in process development and troubleshooting.
ResponsibilitiesMaintain the validation program for computer systems, facilities, equipment, and manufacturing processes.Coordinate, perform, and schedule requalifications and periodic reviews per the validation program.Identify and assess instrumentation for the calibration program and schedule periodic calibration activities.Develop and document written qualification and validation protocols and reports.Perform and assist with IQ/OQ/PQ and other validation activities.Conduct various testing procedures such as temperature monitoring, TOC analysis, LAL (Endotoxin), environmental monitoring, bioburden testing, sterility testing, chemical analysis, physical analysis according to SOPs.Develop and document SOPs as required for current Good Manufacturing Practices (cGMP).Implement document changes and control procedures.Conduct QA investigations and follow-up.Prepare and document procedures and protocols, including commercial batch record preparation and review.Assist, coordinate, perform, and schedule material qualifications.Participate in Risk Analysis (FMECA’s), as assigned.Assist with process development for targeted products.Qualify and review maintenance procedures and schedules for process equipment.Troubleshoot and take corrective action for processing deviations.Essential SkillsExperience in facilities maintenance, equipment maintenance, and corrective action plans.Proficiency in process validation, product validation, and equipment validation.Background in quality control, quality assurance, and inspection.Experience in pharmaceutical and regulated industry settings.Knowledge of aseptic techniques and mechanical/electro-mechanical processes.Proficient in report writing and computer skills, including Microsoft Office Professional.Additional Skills & QualificationsA 2-year technical degree is preferred.1-2 years of relevant experience in the Pharmaceutical/Biotechnology industry is preferred.Familiarity with GMP procedures and requirements, including Quality Systems and cGMP requirements (FDA, EU, ICH).Ability to assess compliance risks.Familiarity with data acquisition systems and protocols.Work Environment
Work in a pharmaceutical manufacturing setting with flexible hours from Monday to Friday, 8am to 5pm. Join a collaborative team of 5 Engineers and 1 Technician. Enjoy a family-oriented team environment with opportunities for growth, learning, and advancement, along with quarterly events, holiday celebrations, and employee recognition.
Pay and BenefitsThe pay range for this position is $35.00 - $42.50/hr.
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 Santa Ana,CA.
Application Deadline
This position is anticipated to close on Jun 30, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.