Senior Quality Assurance Specialist - Medical Device Testing at Eurofins Lancaster Laboratories Inc. in Lancaster, Pennsylvania

Job Description:

Senior Quality Assurance Specialist -
Medical Device Testing



Employee Responsibilities:

• Applies GMP/GLP/ISO IEC 17025 in all areas of responsibility, as appropriate


• Demonstrates and promotes the company vision
  
• 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

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)


• At least three years of laboratory experience with knowledge of regulatory requirements


• Authorization to work in the United States indefinitely without restriction or sponsorship

What we offer:

• 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

The position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed.

As a part of Eurofins BioPharma Product Testing - the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide - Eurofins Lancaster Laboratories provides comprehensive laboratory services for the world's largest pharmaceutical, biopharmaceutical and medical device companies. Our service offering includes comprehensive chemistry, biochemistry, microbiology, molecular and cell biology and biosafety testing of drug substances, final products, intermediates, and starting materials for both small and large molecule drug products.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.


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