Pay Rate Low: 40 | Pay Rate High: 58
QA Specialist II / III - Batch Record Review📍 Location: Carlsbad, CA
🕒 Schedule: Monday-Friday | 8:00 AM - 5:00 PM
(Flexible start times based on production needs; some team members begin as early as 6:00 AM)
💲 Pay Range:
• QA Specialist II: $35 - $45/hr
• QA Specialist III: $45 - $58/hr
- 1 year contract with possibility of extension/conversion
Key Responsibilities• Perform detailed review of production batch records to ensure compliance with GMP requirements and internal quality standards
• Review highly detailed documentation packages ranging from several hundred to tens of thousands of pages
• Review chromatograms and supporting analytical documentation for accuracy and completeness
• Identify discrepancies, deviations, or compliance concerns and escalate findings to Quality Management
• Support quality systems activities including documentation review, archiving, scanning, and record verification
• Verify scans of batch production records (BPRs), chromatograms, and GMP documentation prior to archival
• Maintain accurate organization and archival of GMP records and supporting documentation
• Provide support during internal, customer, and regulatory audits
• Assist with continuous improvement initiatives and quality system support activities
• Collaborate cross-functionally with Manufacturing, QC, and Quality teams to ensure compliance and documentation accuracy
Qualifications QA Specialist II• Bachelor's degree in a scientific discipline preferred
• 3-5 years of QA experience within pharmaceutical, biotech, or biopharma manufacturing environments
QA Specialist III• Bachelor's degree in a scientific discipline preferred
• 5-7 years of QA experience within pharmaceutical, biotech, or biopharma manufacturing environments
Additional Requirements• Strong experience reviewing batch records within GMP-regulated manufacturing environments
• Strong understanding of GMP documentation practices and quality systems
• Experience reviewing chromatograms strongly preferred
• Exceptional attention to detail and organizational skills
• Ability to manage large volumes of documentation in a fast-paced environment
• Proficiency with Microsoft Office applications
• Associate degree candidates with equivalent GMP experience will also be considered
Additional Information• Team Size: Approximately 10 employees
• Reports To: QA Manager
• Interview Process: One onsite interview (~1 hour) with quick decision turnaround
• Start Date: ASAP
• Background check and drug screen required
INDBH
#LI-ES1
