Senior Quality Specialist, Medical Devices - GMP/QA

Eurofins; Lancaster (Lancaster County); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical coverage

Dental & Vision

Life Insurance

401(k) matching

Paid vacations

Job summary

Eurofins USA BioPharma Services, Lancaster, PA, is seeking a quality assurance professional to ensure GMP/GLP/ISO IEC 17025 compliance. The role focuses on internal QA audits, review of SOPs, data review, and systemic improvements in laboratory operations.

The ideal candidate has a bachelor’s degree in a science field and at least three years of laboratory experience with regulatory know-how; strong communication and computer skills are essential.

Qualifications

• Bachelor's degree in a science-related field; two years related industry is equivalent to one year of college in related major
• Minimum three years of laboratory experience with knowledge of regulatory requirements
• Authorization to work in the United States indefinitely without restriction or sponsorship

Responsibilities

• Apply GMP/GLP/ISO IEC 17025 in all areas of responsibility
• Perform internal QA audits
• Review client or agency documents and identify requirements outside our usual practices; communicate to technical operations
• Review and approve SOPs
• Keep abreast of QA requirements; consult with clients or regulatory authorities
• Provide information and revision support for updating company publications
• Identify and drive system improvements in QA and laboratory operations
• Demonstrate proficiency with computers for reports and data access
• Perform data review (analytical, validation, investigations) and identify issues
• Review QC data and non-conformance issues; evaluate trends
• Investigate and document QA, method, and regulatory deficiencies; escalate as needed
• Implement and document computer program changes; review system documents

Skills

Strong computer skills

Quality orientation

Organizational skills

Communication

Independent worker

Education

Bachelor's degree in science

Job description

Eurofins USA BioPharma Services, Lancaster, PA, is seeking a quality assurance professional to ensure GMP/GLP/ISO IEC 17025 compliance. The role focuses on internal QA audits, review of SOPs, data review, and systemic improvements in laboratory operations.

The ideal candidate has a bachelor’s degree in a science field and at least three years of laboratory experience with regulatory know-how; strong communication and computer skills are essential.