Quality Assurance Technician I - 2nd Shift

Actalent; Irvine (CA); On-site; USD 33,000 - 34,000; Full time

Job summary

Actalent in Irvine, CA is seeking a Quality Assurance Technician I for 2nd shift to monitor lab process verifications and ensure compliance with GMP and FDA guidelines. Responsibilities include receiving samples, labeling control, and overseeing reinspection, with data integrity as a focus.

The role requires 2+ years in QA in pharma/medical device, a science degree preferred, and SAP experience. The position is on-site, contract-based, with a 12:00 PM–8:00 PM shift.

Qualifications

• 2+ years of QA experience in pharmaceutical or medical device industries.
• Bachelor's degree in a science-related field preferred with GMP experience.
• Proficiency in GMP, quality control inspections, and documentation writing.
• Familiarity with FDA regulations.

Responsibilities

• Monitor lab and manufacturing process verifications to ensure compliance with procedures and specs.
• Perform process monitoring, receive samples, label control, and oversee reinspection.
• Conduct monitoring and sampling for reserved samples.
• Provide quality oversight to ensure data integrity and compliance.

Skills

Quality assurance

GMP compliance

FDA regulations

SAP

Education

Bachelor's degree in a science-related field

Tools

SAP

Job description

Job Title: Quality Assurance Technician I - 2nd ShiftJob Description

The Quality Assurance Technician I is responsible for monitoring lab process verifications to ensure compliance with operating procedures and specifications. This role involves receiving samples, labeling control, overseeing the reinspection process, and sampling for reserved samples. Additionally, the technician provides quality oversight to ensure compliance, including maintaining data integrity.

Responsibilities

• Monitor lab and manufacturing process verifications to ensure compliance with operating procedures and specifications.
• Perform process monitoring, receive samples, label control, and oversee the reinspection process.
• Conduct monitoring and sampling processes for reserved samples.
• Provide quality oversight on processes to ensure compliance, including data integrity.
• Ensure complaint samples are archived as required and maintain records.
• Review documentation to ensure accuracy, practicing Good Documentation Practices (GDP).
• Input samples into SAP.

Essential Skills

• 2+ years of quality experience in a pharmaceutical or medical device industry.
• Bachelors degree in a science-related field preferred with relevant GMP experience.
• Proficiency in GMP, quality control inspections, and documentation writing.
• Familiarity with FDA regulations.

Additional Skills & Qualifications

• Assignments are routine and require following established procedures and guidelines according to SOPs.
• Ability to stand for long periods and lift 20-35 lbs.
• Experience working in a lab environment.

Work Environment

The work environment is dynamic and fast-paced, reflecting the high standards and demands of the medical device industry. It involves working with advanced technologies and equipment to manufacture sterile saline and syringes for major hospitals and clinics. The position is part of a very busy 24/7 pharmaceutical manufacturing operation, offering stable work. The shift is Monday to Friday, from 12:00 PM to 8:00 PM. GMP training will be conducted on a Monday from 12:30 PM to 4:30 PM. Employees must be comfortable with standing and lifting 20-35 lbs during shifts.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $24.50 - $25.00/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 Irvine,CA.

Application Deadline

This position is anticipated to close on Oct 20, 2026.

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.