Quality Assurance Technician II - 3rd Shift

Actalent; Irvine (CA); On-site; USD 36,000 - 39,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability insurance

HSA

Transportation benefits

Employee Assistance Program

Time Off/Leave

Job summary

Actalent is seeking a Quality Assurance Technician II for a night-shift contract role in Irvine, CA. You will ensure sterile saline products meet quality standards, perform sampling, and maintain GDP-compliant records while inputting data in SAP.

The role emphasizes GMP/QA oversight, documentation accuracy, and problem solving in a fast-paced environment with regulatory compliance requirements.

Qualifications

• 2+ years of quality experience in the pharmaceutical or medical device industry.
• GMP experience in a regulated environment.
• Proficiency in FDA-regulated QA processes and quality control inspections.
• GDP documentation practices.
• Ability to input and manage data in SAP or similar enterprise software.
• Ability to follow SOPs and guidelines.
• Able to stand for long periods and lift 2035 lbs.

Responsibilities

• Monitor laboratory and manufacturing process verifications to ensure compliance with operating procedures, specifications, and established standards.
• Perform process monitoring activities, including receiving samples, controlling labels, overseeing the reinspection process, and conducting sampling for reserved samples.
• Provide quality oversight on processes to ensure compliance with internal procedures and regulatory requirements, with a strong focus on data integrity.
• Support quality investigations by gathering data, reviewing records, and assisting in the resolution of quality issues.
• Ensure complaint samples are archived as required and maintain accurate, organized records of all sample-related activities.
• Review documentation for accuracy and completeness while consistently practicing Good Documentation Practices (GDP).
• Input and manage sample information in SAP to ensure accurate tracking and traceability.
• Perform quality control inspections and physical testing of IV saline bags and related products according to established procedures and Good Manufacturing Practices (GMP).
• Follow all SOPs and guidelines, completing routine and repetitive assignments with a high degree of accuracy.

Skills

Quality Assurance

GMP

GDP

Data integrity

Documentation

Quality investigations

Lab testing

Education

Bachelor's degree in science

Tools

SAP

ERP systems

Job description

Job Title: Quality Assurance Technician II 3rd ShiftJob Description

The Quality Assurance Technician II plays a key role in ensuring that laboratory and manufacturing processes meet strict quality standards for sterile saline and related medical products. You will monitor process verifications, manage sample handling and reinspection activities, and provide quality oversight to maintain compliance with procedures, specifications, and regulatory expectations. This position focuses on maintaining data integrity, supporting quality investigations, and ensuring accurate documentation in a fast-paced, highly regulated environment on the 3rd shift.

Responsibilities

• Monitor laboratory and manufacturing process verifications to ensure compliance with operating procedures, specifications, and established standards.

• Perform process monitoring activities, including receiving samples, controlling labels, overseeing the reinspection process, and conducting sampling for reserved samples.

• Provide quality oversight on processes to ensure compliance with internal procedures and regulatory requirements, with a strong focus on data integrity.

• Support quality investigations by gathering data, reviewing records, and assisting in the resolution of quality issues.

• Ensure complaint samples are archived as required and maintain accurate, organized records of all sample-related activities.

• Review documentation for accuracy and completeness while consistently practicing Good Documentation Practices (GDP).

• Input and manage sample information in SAP to ensure accurate tracking and traceability.

• Perform quality control inspections and physical testing of IV saline bags and related products according to established procedures and Good Manufacturing Practices (GMP).

• Follow all Standard Operating Procedures (SOPs) and guidelines, completing routine and repetitive assignments with a high degree of accuracy.

• Handle, carry, and inspect 500 ml and 1L saline bag samples, transferring them safely from one area to another.

• Adhere to all applicable GMP, FDA, and internal quality assurance requirements while working in a fast-paced laboratory environment.

Essential Skills

• 2+ years of quality experience in the pharmaceutical or medical device industry.

• Hands-on experience working under Good Manufacturing Practices (GMP) in a regulated environment.

• Practical knowledge of FDA-regulated quality assurance processes and quality control inspections.

• Proficiency in documentation writing and review, with consistent application of Good Documentation Practices (GDP).

• Ability to input and manage data in systems such as SAP or similar enterprise software.

• Capability to perform routine and repetitive assignments while strictly following SOPs and established guidelines.

• Ability to stand for long periods and lift 2035 lbs, including handling and transferring 500 ml and 1L saline bags.

• Comfort working in a very fast-paced laboratory environment performing physical testing and re-inspections.

• Strong attention to detail and commitment to maintaining data integrity and accurate records.

Additional Skills & Qualifications

• Bachelors degree in a science-related field preferred, with relevant GMP experience.

• Experience in the pharmaceutical or medical device industry, particularly in sterile product manufacturing, is highly desirable.

• Familiarity with quality assurance principles, including investigation support and complaint sample handling.

• Ability to follow detailed SOPs and work instructions consistently.

• Strong organizational skills for managing samples, documentation, and archival requirements.

• Comfort working independently on night shifts while collaborating effectively with cross-functional teams when needed.

Work Environment

This role is based in a very fast-paced, GMP-compliant laboratory and manufacturing environment that operates around the clock to produce sterile IV saline bags and syringes for major hospitals and clinics. You will work with advanced technologies and equipment to perform physical testing, re-inspections, and quality control inspections of saline bags. The position follows a Monday to Friday night shift schedule from 8:30 PM to 5:30 AM, with overtime opportunities available as needed. GMP training is provided and may occur during a daytime session. The work requires frequent standing, walking, and lifting 2035 lbs while handling and transferring 500 ml and 1L saline bags between areas. The environment is highly regulated, emphasizing Good Manufacturing Practices, Good Documentation Practices, data integrity, and adherence to SOPs. You will work in a clean, controlled setting typical of pharmaceutical and medical device production, focused on safety, quality, and reliability, and offering stable work in a busy, production-driven operation.

Job Type & Location

This is a Contract position based out of Irvine, CA.

Pay and Benefits

The pay range for this position is $26.50 - $27.00/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.

• 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 Irvine,CA.

Application Deadline

This position is anticipated to close on Oct 17, 2026.

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 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.