Quality Control Specialist (Regulated Industry) 3562890

ProQuality Network; United States; Hybrid; USD 60,000 - 85,000; Full time

Job summary

ProQuality Network is seeking a Quality Control Specialist (Regulated Industry) to support laboratory operations in a highly regulated environment. The role emphasizes complex technical challenges and data analysis within molecular biology and microbiology labs.

The position focuses on laboratory compliance, technical troubleshooting, and continuous improvement of quality processes, with collaboration across multi-site teams and interaction with regulatory agencies as needed.

Qualifications

• Advanced technical and scientific writing capabilities; able to analyze data and report findings.
• Experience in pharmaceutical or regulated industry; knowledge of GMP and CFR.

Responsibilities

• Provide technical guidance, reports, and data analysis to cross-functional teams.
• Investigate, troubleshoot, and resolve technical issues related to laboratory assays and testing methods.
• Ensure laboratory compliance with GMP, GLP, and safety standards by implementing and improving procedures.
• Manage existing programs and support development and implementation of new processes and quality initiatives.
• Develop, revise, and audit complex controlled documentation that may impact multiple sites.
• Review and approve laboratory investigations and support or lead audit activities.
• Serve as SME and assist in developing technical training programs.

Skills

GMP compliance

Quality analysis

Technical writing

Cross-functional collaboration

Regulatory knowledge

Data analysis

Education

Doctorate in a relevant scientific field

Master’s degree + 2 years of related experience

Bachelor’s degree + 4 years of related experience

Associate’s degree + 8 years of related experience

High School Diploma/GED + 10 years of related experience

Tools

Excel

Computer system validation

Method validation

QA software

Job description

Quality Control Specialist (Regulated Industry) 3562890

Job Title: Quality Control Specialist (Regulated Industry) – 3562890

Positions Available: 3

Duration: Approximately 6 Months

Work Schedule: Availability to work administrative and non-standard shifts

Position Summary

Our client is seeking a Quality Control Specialist to support laboratory operations within a highly regulated environment. Under general direction, this role serves as a technical specialist in testing and development within molecular biology and microbiology laboratories.

The position focuses on complex technical challenges and scientific data analysis, often supporting multi-organizational or multi-site initiatives and collaborating with internal and external stakeholders. The successful candidate will contribute to laboratory compliance, technical troubleshooting, scientific reporting, and continuous improvement of quality processes.

Key Responsibilities

• Provide technical guidance, reports, and data analysis, ensuring effective communication among cross-functional technical groups.
• Investigate, troubleshoot, and resolve technical issues related to laboratory assays and testing methods.
• Ensure laboratory compliance with GMP, GLP, and safety standards by implementing and improving procedures.
• Manage existing programs and support the development and implementation of new processes, methodologies, and quality initiatives.
• Develop, revise, and audit complex controlled documentation that may impact multiple organizations or sites.
• Review and approve laboratory investigations and support or lead audit activities.
• Serve as Subject Matter Expert (SME) when required and assist in the development of technical training programs.
• Perform routine laboratory or technical activities as necessary within the area of responsibility.
• Represent the department on cross-functional teams and independently track and complete multi-site action items.
• Interact with regulatory agencies when required, including the preparation of written responses.
• Collaborate with external resources to resolve technical or operational issues.
• Lead or participate in special projects as assigned by leadership.
• Provide supervision or technical direction to staff when necessary to meet project or operational requirements.

Preferred Qualifications

• Scientific background in Science or Engineering with experience in the pharmaceutical or regulated industry.
• Experience in Quality Control laboratories, laboratory testing, method validation, and method transfer.
• Background in disciplines such as:
• Microbiology
• Molecular Sciences
• Chemical Engineering

Additional preferred skills include:

• Scientific data analysis and interpretation
• Strong technical writing skills in English and Spanish
• Advanced Microsoft Excel for data analysis and trending
• Strong communication and collaboration skills
• Sample lifecycle and sample management processes
• Knowledge of computer system validation and method validation
• Experience with quality process management systems
• Basic knowledge of preventive maintenance and equipment troubleshooting
• Ability to prioritize critical tasks in fast-paced environments
• Capability to develop inspection or qualification protocols within tight timelines
• Strong negotiation and problem-solving skills

Education Requirements

One of the following combinations is required:

• Doctorate in a relevant scientific field, or
• Master’s degree + 2 years of directly related experience, or
• Bachelor’s degree + 4 years of directly related experience, or
• Associate’s degree + 8 years of directly related experience, or
• High School Diploma/GED + 10 years of directly related experience.

Core Competencies and Skills

• Excellent communication, facilitation, and presentation skills.
• Strong technical and scientific writing capabilities.
• Advanced computer proficiency, including word processing, presentations, databases, and spreadsheets.
• Strong project management and organizational skills with the ability to independently follow complex instructions through completion.
• Ability to manage multiple priorities, tasks, and projects simultaneously.
• Extensive experience with quality analytical laboratories, validation, manufacturing, quality assurance, process development, and distribution.
• Strong knowledge of assay development, assay validation, and laboratory testing processes.
• Understanding of pharmaceutical manufacturing and analytical processes.
• Strong knowledge of U.S. pharmaceutical regulations and practices for testing biological and pharmaceutical products.
• Familiarity with international regulatory standards and practices.
• Extensive knowledge and application of GMP and CFR regulations.
• Ability to evaluate and document compliance issues in accordance with company procedures and regulatory guidelines.
• Proficiency in equipment operation, maintenance, and troubleshooting within the technical area of expertise.
• Advanced scientific data analysis, data trending, and interpretation skills.
• Strong analytical thinking and complex problem-solving capabilities.
• Ability to work independently and effectively collaborate with cross-functional teams.
• Experience interacting with regulatory agencies both verbally and in writing.
• Ability to lead, coordinate, and motivate cross-functional teams.