Quality Assurance Specialist II​/III; Pharma

Pay Range: $40–52 per hour.

Location:

Carlsbad, CA.

Schedule:

Monday–Friday, 8:00 AM–5:00 PM (flexible start times; some team members begin as early as 6:00 AM). One‑year contract with the possibility of extension or conversion.

We are seeking a Document Control Specialist to join a global pharmaceutical manufacturing organization supporting critical Quality Assurance operations within a GMP‑regulated environment. This contract opportunity may extend based on business needs. The role focuses heavily on batch record review and documentation oversight to support a major end‑of‑year validation initiative. The ideal candidate will have strong QA experience within pharma, biotech, or biopharma manufacturing environments and exceptional attention to detail when reviewing complex GMP documentation and chromatographic data.

• 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 escalates 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

• Bachelor’s degree in a scientific discipline is preferred
• 3–5 years of QA experience within pharmaceutical, biotech, or biopharma manufacturing environments

• Bachelor’s degree in a scientific discipline is preferred
• 5–7 years of QA experience within pharmaceutical, biotech, or biopharma manufacturing environments

• 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

• Team Size:
  Approximately 10 employees
• Reports To:
  
  QA Manager
• Interview Process:
  One onsite interview (approximately 1 hour) with quick decision turnaround
• Start Date:
  
  ASAP
• Background check and drug screen required