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Document Control Specialist (Pharma)

Job

Astrix Technology

Vista, CA (In Person)

$95,680 Salary, Full-Time

Posted 1 week ago (Updated 1 week ago) • Actively hiring

Expires 7/28/2026

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Job Description

  • Document Control Specialist (Pharma)
  • Quality Assurance Vista, California, US + Added - 17/06/2026
Pay Rate Low:
40 |
Pay Rate High:
52
  • Document Control Specialist
  • _•MUST have QC data chromatogram review experience as well•_•?
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:
$40-52/hr + 1 year contract with possibility of extension/conversion
  • About the Opportunity
  • 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 is a contract opportunity with potential for extension based on business needs. This role will focus heavily on batch record review and documentation oversight in support of a major end-of-year validation initiative. The ideal candidate will bring strong QA experience within pharma, biotech, or biopharma manufacturing environments and possess exceptional attention to detail when reviewing complex GMP documentation and chromatographic data. This is an excellent opportunity to join a highly respected global API manufacturer headquartered in Switzerland and work alongside industry leaders in pharmaceutical manufacturing and quality systems.
  • 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-ES1We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.