Quality Control Specialist (Regulated Industry) 3562822

ProQuality Network; United States; Hybrid; USD 70,000 - 100,000; Full time

Job summary

ProQuality Network seeks a Quality Control Specialist (Regulated Industry) to provide technical leadership in molecular biology and microbiology testing within a GMP/GxP regulated environment.

The role requires collaboration across departments and sites, with responsibilities including testing development, equipment validation, documentation, and regulatory interactions. Onsite contract position with cross-functional team leadership.

Qualifications

• Must have extensive experience in regulated laboratory environments.
• Proficient in laboratory testing and validation activities.
• Strong technical writing and documentation skills.
• Ability to lead cross-functional teams and manage complex projects.

Responsibilities

• Provide technical guidance and SME for laboratory testing and development.
• Prepare technical reports, data analysis, and documentation for cross-team use.
• Troubleshoot and resolve laboratory assay and analytical testing issues.
• Ensure GMP, GLP, and safety regulatory compliance in operations.
• Develop and improve laboratory programs, processes, and methodologies.
• Review and audit complex controlled documentation across sites.

Skills

Technical leadership

Laboratory support

GMP/GLP knowledge

Laboratory analytics

Education

Engineering (Chemical/Environmental/Mechanical/Electrical)

Chemistry or Biology degree + Equipment Validation

Tools

Equipment Validation

Job description

Quality Control Specialist (Regulated Industry) 3562822

Position Title: Quality Control Specialist (Regulated Industry) – 3562822

Work Modality: 100% Onsite

Schedule: Administrative and Non-Standard Shifts (as required)

Type: Contract Position (Approximately 6 Months)

Open Positions: 1

Position Summary

Our client is seeking a Quality Control Specialist to provide technical leadership and laboratory support in molecular biology and microbiology testing environments within a regulated industry.

Under general direction, the selected professional will serve as a technical specialist, addressing complex laboratory and analytical issues while supporting testing development, equipment validation, compliance, and quality operations. This role may involve collaboration across multiple departments, sites, and external partners.

Preferred Qualifications

Candidates with experience in regulated laboratory environments are highly preferred.

Education Background

• Engineering (Chemical, Environmental, Mechanical, Electrical), OR
• Chemistry or Biology degree with experience in Equipment Validation

Laboratory Equipment Validation Experience

• Periodic Monitoring
• Periodic Review
• Equipment Data Integrity
• Equipment Procurement
• New Equipment Introduction and Maintenance

Laboratory Testing Experience

• Compendial testing
• Physical methods
• Sterility
• Endotoxin

Key Responsibilities

• Provide technical guidance and subject matter expertise for laboratory testing and development activities.
• Prepare technical reports, data analysis, and documentation, ensuring clear communication between technical teams.
• Troubleshoot and resolve technical issues related to laboratory assays and analytical testing.
• Ensure laboratory operations remain compliant with GMP, GLP, and safety regulations.
• Develop, implement, or improve programs, processes, and laboratory methodologies.
• Develop, revise, and audit complex controlled documentation that may impact multiple departments or sites.
• Review and approve laboratory investigations and participate in or lead internal audit activities.
• Serve as subject matter expert (SME) and contribute to technical training programs.
• Represent the department on cross-functional teams and ensure follow-up on multi-site action items.
• Interact with regulatory agencies as required, including providing written responses.
• Coordinate with external partners or vendors to resolve technical issues.
• Support special projects and technical initiatives assigned by management.
• Provide technical supervision or mentorship when necessary.

Education Requirements

Candidates must meet one of the following:

• Doctorate (PhD) in a related discipline, OR
• Master’s Degree + 2 years of relevant experience, OR
• Bachelor’s Degree + 4 years of relevant experience, OR
• Associate’s Degree + 8 years of relevant experience, OR
• High School Diploma/GED + 10 years of relevant experience
• Strong understanding of quality analytical laboratory processes and regulated manufacturing environments.
• Extensive knowledge of GMP, GLP, CFR regulations, and compliance practices.
• Experience with analytical testing, assay development, and validation.
• Strong knowledge of pharmaceutical and biologics testing processes.
• Experience supporting quality assurance, process development, and validation activities.
• Ability to evaluate compliance issues and implement corrective actions.
• Advanced scientific data analysis, trending, and interpretation skills.
• Experience maintaining, troubleshooting, and operating laboratory equipment.
• Excellent technical writing and documentation skills.
• Strong communication, presentation, and facilitation abilities.
• Excellent project management and organizational skills.
• Ability to manage multiple priorities and complex technical assignments simultaneously.
• Ability to lead cross-functional teams and collaborate across organizational levels.
• Strong problem-solving and decision-making skills.
• Ability to interact with regulatory agencies both verbally and in writing.
• Proficiency with computer systems and data management tools (Word, Excel, presentations, databases).