Quality Control Specialist (3500410)

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

Title: Quality Control Specialist (3500410)

Work Model: 100% Onsite – Administrative Shift

Positions: 1

Contract: Approximately 7 months, by contract with ProQuality Network

Summary

Our client is seeking 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 with multi-site, multi-organizational, and external resource impact.

Preferred Qualifications

A strong scientific or engineering background is preferred, including experience in the pharmaceutical industry, Quality Control, laboratory testing, and quality processes. Relevant 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)
• Experience with quality process management
• Basic knowledge of equipment preventive maintenance and troubleshooting
• Ability to prioritize critical tasks effectively
• Capability to develop inspection or qualification protocols within short timelines
• Strong negotiation and interpersonal skills

Functions

• 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.

Education Requirements

• Doctorate, OR
• Master’s degree + 2 years of directly related experience, OR
• Bachelor’s degree + 4 years of directly related experience, OR
• Associate degree + 8 years of directly related experience, OR
• High school/GED + 10 years of directly related experience.
• Demonstrated support and alignment with organizational values.
• Excellent communication, facilitation, and presentation skills.
• Strong technical writing capabilities.
• Advanced proficiency in computer applications, including databases, presentations, and spreadsheets.
• Exceptional project management and organizational skills.
• Ability to independently interpret and execute complex instructions.
• Strong multitasking abilities with flexibility to shift priorities as needed.
• Extensive experience in analytical laboratory processes, validation, manufacturing, quality assurance, process development, and distribution.
• Deep understanding of pharmaceutical testing, assay development, and validation.
• Knowledge of pharmaceutical and biological manufacturing processes.
• Strong understanding of U.S. and basic international regulations for pharmaceutical/biological product testing.
• Extensive knowledge and application of GMPs/CFRs.
• Ability to assess and document compliance issues.
• Proficiency in equipment maintenance, troubleshooting, and operation within area of expertise.
• Advanced scientific data analysis, interpretation, trending, and problem-solving skills.
• Strong independent work ethic and ability to collaborate effectively at all organizational levels.
• Ability to communicate effectively with regulatory agencies (oral and written).
• Ability to initiate, coordinate, and lead cross-functional teams.
• Strong leadership, motivation, influence, and negotiation skills.