Senior Quality Specialist Medical Device

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 SOPs
• 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 :

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:

• Bachelors 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

Additional Information :

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 are encouraged to apply.

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.

Remote Work :

No

Employment Type :

Full-time