Biologics Quality Specialist

Infotree Global Solutions; Salt Lake City (UT); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company in the biotechnology sector is seeking a detail-oriented Biologics Quality Specialist for their Quality Assurance team in Salt Lake City, UT. The role involves managing electronic documentation in a regulated environment, ensuring compliance with internal standards and regulatory requirements. Ideal candidates will have a background in quality systems, strong organizational skills, and a Bachelor’s degree in a relevant field.

Qualifications

• 1+ years of experience in regulatory, quality, or compliance within the pharmaceutical or biotechnology industry.
• Familiarity with EDMS and QMS.
• Understanding of GxP principles and FDA regulations.

Responsibilities

• Manage Document Change Requests within the electronic document management system.
• Ensure timely review and approval of controlled documents including SOPs.
• Maintain compliance with cGMP, FDA, and other regulatory guidelines.

Skills

Organizational skills

Communication skills

Interpersonal skills

Education

Bachelor’s Degree in Science (Biology preferred)

Tools

Electronic Document Management Systems

Quality Management Systems

Job description

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Infotree Global Solutions provided pay range

This range is provided by Infotree Global Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$19.00/hr - $21.00/hr

Direct message the job poster from Infotree Global Solutions

Technical Recruiter at Infotree Global Solutions(Hiring for USA, UK, Sweden and other Nordic Countries)

Position Summary:

We are seeking a detail-oriented and organized Biologics Quality Specialist to join our Quality Assurance team. This role will be responsible for managing electronic documentation and record control systems in a regulated pharmaceutical/biotech environment. The ideal candidate will have experience with document lifecycle management, including periodic review, retention, archival, and change control processes. This position plays a key role in ensuring compliance with applicable regulatory requirements and internal quality standards.

Key Responsibilities:

• Coordinate, initiate, route, and manage Document Change Requests (DCRs) within the electronic document management system (EDMS).
• Ensure timely review, approval, and implementation of controlled documents including SOPs, work instructions, and forms.
• Oversee document retention, periodic review schedules, and secure storage of electronic and physical quality records.
• Maintain compliance with cGMP, FDA, and other regulatory guidelines related to document and record control.
• Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and other departments to ensure accurate and up-to-date documentation.
• Participate in internal audits and inspections by providing appropriate documentation and record-keeping support.
• Support continuous improvement initiatives in quality systems and document lifecycle management.

Qualifications:

• Bachelor’s Degree from an accredited college or university in Science (Biology preferred), Business, Education, or related field.
• 1+ years of experience in regulatory, quality, or compliance within the pharmaceutical or biotechnology industry.
• Familiarity with electronic document management systems (EDMS) and quality management systems (QMS).
• Understanding of GxP principles, FDA regulations (21 CFR Part 11), and ICH guidelines.
• Excellent organizational, communication, and interpersonal skills.
• Experience working with biologics or aseptic manufacturing environments.
• Prior use of systems such as Veeva Vault, MasterControl, or similar QMS platforms.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing

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