Senior Quality Specialist: Medical Device

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

Job Description

• Applies GMP/GLP/ISO IEC 17025 in all areas of responsibility, as appropriate
• Perform internal quality assurance audits
• Review client or agency documents and identify requirements outside our usual practices, communicate to technical operations, assist with implementing appropriate changes
• Perform review and approval of SOP's
• Keep abreast of regulatory or industry quality assurance (QA) requirements, consult with clients or regulatory authorities regarding any special QA requirements they may have, assist technical operations with application and interpretations
• Provide information and revision support for updating company publications including quality policy manuals, company web site, and newsletters
• Identify and drive system improvements, both within the department and for laboratory operations; determine the most effective way to accomplish a goal or strategy; suggest improvements to maximize quality and productivity
• Demonstrate skill in using the computer to access information, perform job functions (e.g., spreadsheets, power point), and prepare other reports
• Perform data review (analytical, validation, investigations), review for compliance and identify issues, provide options for resolution
• Review QC data and non-conformance issues for assigned technical groups, evaluate for trends or patterns
• Investigate and document QA, method, and regulatory deficiencies within the lab; take investigation to next level when needed; diagnose and solve problems independently
• Implement and document computer program changes, review computer system documents, provide feedback to meet regulatory and industry expectations

Qualifications

The Ideal Candidate would possess:

• Strong computer, scientific, quality orientation, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
• Word processing, spreadsheets, PowerPoint, and database experience
• Previous GMP, Root Cause Analysis, and technical writing experience

Minimum Qualifications

• Bachelor's degree in a science-related field or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time 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

Position is Full-time, Monday-Friday, 8 a.m.-5 p.m. , with overtime as needed.

Candidates currently living within a commutable distance of Lancaster, Pennsylvania.

Excellent full-time benefits including:

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

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Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.