Quality Control Specialist – Molecular Biology & GMP Expert

ProQuality Network; United States; Hybrid; USD 65,000 - 110,000; Full time

Job summary

ProQuality Network seeks a highly skilled Quality Control Specialist to serve as a technical expert in molecular biology and microbiology testing and development. This role focuses on complex technical issues impacting multiple sites and external resources.

The candidate should have a strong scientific or engineering background with experience in the pharmaceutical industry, quality control, and laboratory testing.

Qualifications

• Experience in pharmaceutical industry, Quality Control, laboratory testing, and quality processes.
• Backgrounds may include Microbiology, Chemistry, Biochemistry, Molecular Sciences, or Chemical Engineering.
• Scientific data analysis proficiency.
• Strong technical writing skills (English and Spanish).
• Advanced knowledge of Microsoft Excel for data analysis.
• Project management capabilities.
• Knowledge of computer systems and method validation (preferred).

Responsibilities

• Provide technical guidance, generate reports, perform data analysis, and ensure clear communication across technical groups.
• Resolve technical issues and troubleshoot assays as needed.
• Ensure laboratory compliance by implementing and maintaining GMP, GLP, and safety standards.
• Manage or develop new programs, processes, and methodologies.
• Develop, revise, and audit complex controlled documents with multi-site or multi-organizational impact.
• Approve laboratory investigations and lead internal audit teams.
• Serve as a subject matter expert for technical training as needed.
• Perform routine testing or responsibilities within assigned areas.
• Represent the department on cross-functional or multi-site teams and complete assigned action items independently.
• Interact with regulatory agencies, including preparation of written responses.
• Coordinate with external resources to resolve technical issues.
• Execute special projects as assigned by the supervisor.
• Supervise team members as necessary to meet technical or project requirements.

Skills

Scientific data analysis

Technical writing

Project management

Interpersonal skills

Negotiation

Education

Doctorate

Master’s degree + 2 years related experience

Bachelor’s degree + 4 years related experience

Associate degree + 8 years related experience

High school/GED + 10 years related experience

Tools

Microsoft Excel

Job description

ProQuality Network seeks a highly skilled Quality Control Specialist to serve as a technical expert in molecular biology and microbiology testing and development. This role focuses on complex technical issues impacting multiple sites and external resources.

The candidate should have a strong scientific or engineering background with experience in the pharmaceutical industry, quality control, and laboratory testing.