Quality Complaints Specialist

Job Description

Job Description

Job Title: Quality Complaints Specialist

Job Description

The Quality Complaints Specialist will operate within a high-volume complaints and investigations team, specifically in a very fast paced pharmaceutical manufacturing environment. This role requires a strong focus on customer complaint (PIR) investigations, risk analysis, and root cause analysis. The ideal candidate should be highly experienced, quick to learn, and adept at managing a significant complaint backlog in a fast-paced, fully onsite setting.

Responsibilities

• Establish quality standards for products and processes and suggest modifications to prevent defects in components or final products.
• Collaborate closely with cross-functional teams, including production, to identify and mitigate quality risks.
• Audit processes, raw materials, or suppliers/vendors to ensure that established quality standards are met.
• Conduct root cause analysis and ensure compliance with formal external quality standards, such as ISO 9001.
• Review and support investigations and manage a high volume of investigations.
• Perform investigations when technical writing support is unavailable.
• Evaluate defective samples and units to support investigations and root cause analysis.
• Provide direction and hands-on assistance to the complaints team.
• Perform risk assessments, assess defect severity, and determine potential impact.
• Ensure compliance with FDA CFR requirements and guidance documents.
• Manage a sustained workload of complaints, including an active backlog.

Essential Skills

• Experience in sterilization, quality assurance, medical devices, inspection, SOPs, document control, quality investigations.
• Proficiency in risk assessment, compliance, quality engineering, corrective action plans, and validation.
• Bachelor's degree in Science, preferably Chemistry, or other related sciences.
• 5-7 years of quality experience and 5-10 years of experience working in GMP environments.
• Experience in pharmaceutical manufacturing is required.

Additional Skills & Qualifications

• Experience with pharmaceutical complaint handling as a regulated Quality Management System (QMS) process.

Work Environment

The work environment is dynamic and fast-paced, reflecting the high standards and demands of the pharmaceutical industry.

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

The pay range for this position is $55.00 - $60.00/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)

This is a fully onsite position in Irvine,CA.

This position is anticipated to close on Jul 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 View email address on ziprecruiter.com 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.