Talantix.io
Apogee Therapeutics•02.03.26
AI SCORE 8.5

Remote QA Document Control Specialist - Biotechnology

$80K–$100K/year
RemoteBiotechnology
Document Control•Quality Assurance•Regulatory Compliance•GMP•GCP•EDMS

About the Role

We are seeking a Remote QA Document Control Specialist to join our dynamic team at Apogee Therapeutics. This role offers an exciting opportunity to contribute to our innovative biotechnology projects while working remotely. As a Remote QA Document Control Specialist, you will play a crucial role in ensuring the quality and compliance of our documentation processes.

What You'll Do

  • Manage and maintain the document control system, ensuring all documents are accurately tracked and archived.
  • Review and approve documentation related to quality assurance processes.
  • Collaborate with cross-functional teams to ensure compliance with regulatory standards.
  • Conduct audits of documentation to ensure adherence to company policies and procedures.
  • Assist in the development and implementation of quality assurance protocols.

Requirements

  • Bachelor's degree in a relevant field or equivalent experience.
  • 2-5 years of experience in quality assurance or document control, preferably in the biotechnology or pharmaceutical industry.
  • Strong understanding of regulatory requirements and quality management systems.
  • Excellent attention to detail and organizational skills.
  • Proficient in document management software and Microsoft Office Suite.

Nice to Have

  • Experience with electronic document management systems (EDMS).
  • Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
  • Certifications in quality assurance or related fields.

What We Offer

  • Competitive salary and benefits package.
  • Flexible remote work environment.
  • Opportunities for professional growth and development.
  • A supportive and inclusive company culture.
  • Engagement in meaningful work that impacts patient care.
Why This Job8.5 of 10

This Remote QA Document Control Specialist role at Apogee Therapeutics offers a unique opportunity to work in a fast-paced biotech environment with a focus on quality assurance and compliance.

Salary Range
Required
0/1
Optional
0/1
Bonus
0/1

Who Will Succeed Here

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Proficient in Document Control Systems such as Veeva Vault or MasterControl, ensuring adherence to regulatory compliance standards like GMP and GCP.

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Self-motivated and detail-oriented, capable of managing multiple documentation tasks independently in a fully remote environment, while maintaining high organizational skills.

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Strong understanding of biotechnology regulations and experience in quality assurance processes, with a mindset focused on continuous improvement and compliance oversight.

Learning Resources

→Document Control Best Practicesarticle
→Quality Assurance in Biotechnologycourse
→Understanding GMP and GCP Regulationscourse

Career Path

Remote QA Document Control Specialist(Now)→QA Manager(1-2 years)→Director of Quality Assurance(3-5 years)

Market Overview

Market Size 2024
$5.2B
Annual Growth
12.5%
AI Adoption in QA
35%
Investment in EDMS Technologies
+20%
Labour Demand for QA Specialists
+15%
Avg Salary for QA Document Control Specialists
$85K

Skills & Requirements

Required
Document ControlQuality AssuranceRegulatory Compliance
Growing in Demand
Data AnalyticsAutomated Testing ToolsRegulatory Affairs Knowledge
Declining
Manual Testing ProcessesTraditional Document Management Systems (DMS)

Domain Trends

Increased Automation in QA Processes
Over 40% of biotechnology companies are adopting automated QA processes, reducing time spent on manual tasks.
Shift Towards Cloud-Based EDMS
The adoption of cloud-based Electronic Document Management Systems has increased by 30% as companies seek more efficient and scalable solutions.
Regulatory Compliance Focus Intensifies
Approximately 60% of biotech firms report a heightened focus on regulatory compliance, driven by evolving global standards.

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