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.
