Senior Quality Specialist (Medical Device)

Location: Lancaster, Pennsylvania, USA; onsite, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed

Company

International life sciences and laboratory testing organization providing analytical, pharmaceutical, environmental, food, cosmetic, clinical, and medical-device testing services.

What you will do

• Apply GMP, GLP, and ISO/IEC 17025 requirements across assigned responsibilities.
• Perform internal quality assurance audits and review SOPs for approval.
• Review client and regulatory documents, identify non-standard requirements, and support implementation with technical operations.
• Review analytical, validation, investigation, QC, and non-conformance data for compliance, trends, and resolution options.
• Investigate and document QA, method, and regulatory deficiencies, escalating complex issues when necessary.
• Drive laboratory and departmental system improvements, including computer program changes and supporting documentation.

Requirements

• Bachelor's degree in a science-related field or equivalent directly related experience.
• At least three years of laboratory experience with knowledge of regulatory requirements.
• Authorization to work indefinitely in the United States without restriction or sponsorship.
• Previous GMP, root cause analysis, and technical writing experience.
• Strong scientific, quality, organizational, communication, computer, and documentation skills.
• Ability to work independently, manage multiple tasks, maintain accurate records, and collaborate effectively.

Culture & Benefits

• Full-time employment with paid vacation and holidays.
• Medical, dental, and vision coverage options.
• Life and disability insurance.
• 401(k) plan with company match.
• Work in a decentralized, entrepreneurial international laboratory network.