Senior Quality Specialist: Medical Device

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 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 #LI-EB1 Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer. Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.