Quality Control Technician; Quality Engineer

Job Title:
Quality Control Technician (Quality Engineer Contract)

Location: 100% Remote (Preferred Eastern or Central Time Zones)

Duration: 12 Months

Schedule: Full-Time, 40 Hours/Week | Standard Business Hours

Conversion: No FTE conversion available

Interview Process: 1 Round

We are seeking an experienced Quality Control Technician with strong validation and quality systems expertise to support documentation, statistical quality control, and regulatory compliance initiatives in a highly regulated pharmaceutical or manufacturing environment.

This role focuses on validation documentation, quality analysis, regulatory compliance, and cross-functional collaboration to ensure systems, products, and processes meet defined reliability and regulatory standards.

• Write, review, approve, and execute validation documentation and technical reports for systems, products, and processes
• Prepare validation protocols, test equipment, and evaluate validation data
• Conduct statistical quality control analysis of testing results and process anomalies
• Prepare reports summarizing study results and conformance to acceptance criteria
• Support development and maintenance of validation programs and Standard Operating Procedures (SOPs)
• Verify calibration, maintenance, and repair of instruments supporting Quality Systems validation
• Participate in FMEA, RCA, and CAPA development activities
• Ensure corrective and preventive measures meet reliability and compliance standards
• Maintain working knowledge of FDA, CLIA, cGMP, Medical Device Directives, and other applicable regulatory standards
• Support procedural document management and regulatory audit readiness
• Communicate cross-functionally regarding validation studies and project deliverables

• Bachelor's degree in Science, Engineering, or related field (or equivalent combination of education and relevant experience)
• Minimum 3 years of quality/validation experience in pharmaceutical manufacturing or a highly regulated industry
• Strong working knowledge of cGMP principles and regulatory compliance requirements
• Experience writing and approving validation and technical documentation
• Experience participating in FMEA, RCA, and CAPA processes
• Strong analytical, critical thinking, and problem-solving skills
• Project management skills with ability to manage multiple priorities and tight deadlines
• Proficiency in Microsoft Office, statistical tools, and electronic quality systems
• Strong written, verbal, and interpersonal communication skills
• Ability to maintain confidentiality and demonstrate professional judgment

• ASQ Certification
• Experience in medical device or regulated laboratory environments

This remote contract opportunity is ideal for a quality professional with deep validation experience, strong regulatory knowledge, and the ability to drive compliance and quality excellence within a regulated pharmaceutical or manufacturing environment.