Compliance Analyst

Position: Compliance Analyst
Location: 4038 Avenida De La Plata, Oceanside, CA
Duration: 6-month contract (with potential for extension or conversion to a permanent role)
Compensation: $25.00 – $49.53/hr (W2)
Benefits: Weekly pay, medical, dental, and vision coverage
 
Position Overview
The Compliance Analyst is responsible for ensuring adherence to cGMP standards while supporting cross-functional teams in resolving technical and compliance-related issues. This role requires strong problem-solving skills, regulatory knowledge, and the ability to manage complex quality and manufacturing challenges in a fast-paced environment.
 
Key Responsibilities

• Manage and resolve technical and compliance issues across Quality, Technology, Maintenance, Facilities, Calibration, and EH&S.
• Address complex, cross-functional challenges by applying advanced technical knowledge and cGMP principles.
• Troubleshoot quality issues and drive resolution through strong collaboration with cross-functional teams.
• Conduct technical assessments for document changes; review and approve Change Requests.
• Support discrepancy investigations, ensuring proper identification, evaluation, and resolution.
• Serve as a Subject Matter Expert (SME) during regulatory inspections and audits.
• Identify risks related to processes, procedures, and equipment, and implement effective solutions.
• Lead and track Corrective and Preventive Actions (CAPA) to ensure timely completion.
• Ensure full compliance with documentation and cGMP standards across operations.
• Maintain a safe manufacturing environment in accordance with company and regulatory requirements.
• Analyze data and support investigations related to out-of-limit conditions in cleanroom environments.
• Lead or support projects aimed at reducing microbial contamination risks.
• Drive timely closure of adverse trends through corrective actions.
• Facilitate Root Cause Analysis (RCA) sessions for complex issues.

 
Discrepancy Management

• Act as Discrepancy Owner Lead, ensuring compliance with internal procedures and cGMP standards.
• Perform initial assessments, participate in triage discussions, and review investigation findings.
• Summarize deviations and coordinate with QA for timely closure.
• Track and manage action items related to deviation resolution through completion.

 
Qualifications
Education & Experience:

• Bachelor’s degree in Life Sciences, Engineering, or related field preferred
• Minimum of 5 years of experience in pharmaceutical or biopharmaceutical environments (or equivalent combination of education and experience)

Skills & Knowledge:

• Hands-on experience with mammalian cell culture and/or biopharmaceutical purification processes
• Strong understanding of cGMP regulations and familiarity with FDA, ICH, and EU guidelines
• Excellent written and verbal communication skills
• Ability to work independently and make sound decisions with minimal supervision
• Proficiency in Microsoft Word, Excel, and Project
• Experience in technical writing, including SOP development and revisions, is a plus
• Strong problem-solving skills with the ability to manage complex assignments

 
Work Environment

• Requires working in a cleanroom environment with appropriate gowning (scrubs, gloves, bunny suit, steel-toe boots)
• Exposure to large-scale manufacturing equipment, piping systems, and high-pressure utilities
• May involve handling hazardous materials