Quality Assurance Specialist

Quality Assurance (QA) Specialist - Chemistry

Location: Irvine, CA 92614

Pay: $45/hour

Job Type: 3-Month Contract

Schedule: 8 hours per day, 5 days per week

Onsite Position

Position Overview

This company is seeking a Quality Assurance (QA) Specialist with a strong chemistry background to support QA oversight of analytical laboratory activities. This role focuses on reviewing chemistry-related documentation and ensuring compliance with GMP regulations and internal quality standards. The ideal candidate will have hands-on laboratory experience and extensive knowledge of analytical techniques and method/equipment qualification.

Key Responsibilities

• Provide QA oversight of analytical chemistry activities, including review of all HPLC, GC, and other analytical testing documentation.
• Review and approve method and equipment qualification packages (IQ/OQ/PQ) and validation activities.
• Ensure compliance with GMP regulations (21 CFR Parts 11, 210, 211), USP standards, and internal SOPs.
• Evaluate technical data for accuracy, completeness, and adherence to established specifications.
• Review laboratory records, reports, and electronic documentation within quality systems.
• Collaborate with chemistry analysts to clarify results, resolve discrepancies, and ensure proper documentation practices.
• Identify gaps, deviations, or nonconformances and escalate issues to the Quality Assurance Manager as needed.
• Support audit readiness by ensuring documentation is inspection-ready and compliant.
• Contribute to continuous improvement efforts within the QA and laboratory functions.

Requirements

• Education: Bachelors Degree in Chemistry or other science related fields
• Minimum of 5 years of experience in a GMP-regulated pharmaceutical or analytical laboratory environment.
• Strong hands-on knowledge of HPLC, GC, and other analytical chemistry techniques.
• Experience with method validation and equipment qualification (IQ/OQ/PQ).
• Prior experience working directly in a laboratory setting is required.
• Strong understanding of 21 CFR Part 11, 210, 211, and USP guidelines.
• Pharmacy or laboratory background is preferred.
• Excellent attention to detail with strong documentation review skills.
• Ability to work independently in a desk-focused QA role.
• Must be able to work onsite and report directly to the Quality Assurance Manager.
• This role does not involve training or supervising others.

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

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