Quality Assurance Batch Record Specialist

2 weeks ago


Fremont, California, United States Planet Pharma Full time

Contract Position Overview

Location: Fremont, CA - Onsite

Compensation: $28 - $35 per hour

Key Responsibilities:

  • Independently conducts quality assurance oversight to ensure compliance with current Good Manufacturing Practices (cGMPs) and Quality Control Systems.
  • Exhibits a high degree of independent judgment in identifying, investigating, and resolving quality-related events affecting products and processes.
  • Ensures compliance with Standard Operating Procedures (SOPs), including proper change control, corrective actions, preventive actions (CAPA), deviation management, and risk assessments related to equipment and processes.
  • Makes critical decisions under time constraints that may directly impact manufacturing operations and the release of systems or equipment.
  • Provides oversight for the change management system, particularly for complex Minor and Major classified Change Controls, ensuring adherence to local SOPs and regulatory standards.
  • Conducts thorough technical reviews of documentation during and after the execution of cGMP activities, confirming that all specifications and requirements are met.
  • Ensures all issues and documentation related to processes in the assigned area are resolved and approved before progressing to subsequent steps, in accordance with cGMPs and site procedures.
  • Analyzes findings and communicates results to relevant departments.

Required Qualifications:

  • Bachelor's degree in Life Sciences or Engineering
  • Minimum of 1 year experience in batch record review within the pharmaceutical or biotechnology sectors
  • Experience working in a GMP environment
  • Preferred experience in a Team Lead or Supervisory role
  • Strong attention to detail, excellent organizational and interpersonal skills, and adept problem-solving abilities.
  • Ability to prioritize tasks and perform under pressure.
  • Capability to work effectively and respond promptly in a dynamic environment.
  • Proficient in MS Office (Word and Excel) and related software applications.
  • Familiarity with SAP systems.
  • Technical understanding of manufacturing systems, methods, and procedures.
  • Exceptional written and verbal communication skills.
  • Comprehensive awareness of manufacturing processes.


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