Quality Assurance Analyst, Sr. - Healthcare jobs in Lancaster, PA

Company Description

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.

Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies.

Job Description

The Quality Assurance (QA) Manager has the authority for and responsibility of developing, implementing, and improving the laboratory Quality System that meets the requirements set forth in the Eurofins Environment Testing Quality Management Plan (QMP). Responsibilities include providing Quality Systems training to all new personnel; maintaining a laboratory Quality Assurance Manual (QAM); arranging and managing proficiency testing (PT) samples; and performing systems, data, special, and external audits with both clients and regulatory officials. The QA Manager oversees the maintenance of quality control (QC) records; maintains certifications; approves, develops, and maintains Standard Operating Procedures (SOPs); submits monthly QA Reports; and assists in reviewing new work as needed. The QA Manager has the final authority to accept or reject data, and to stop work in progress in the event that procedures or practices compromise the validity and integrity of analytical data. The QA Manager is available to any employee at the facility to resolve data quality or ethical issues. The QA Manager is independent of laboratory operations.

Quality Assurance Manager responsibilities include, but are not limited to, the following:

• Lead team, schedule, and train employees
• Ensure adherence to highest quality and efficiency standards in laboratory operations
• Ensure coverage and performance
• Foster morale and teamwork
• Supervises QA Staff
• Review Eurofins Environment Testing’s QMP and ensure compliance with the Eurofins Environment Testing Quality System
• Develop and implement the QAM
• Participate as a member of the laboratory’s senior management team.
• Act as a technical resource and final authority in all matters of data quality
• Act as the focal point for ethics and data integrity issues.
• Conduct and/or oversee QA training courses. As directed by the Laboratory Director, may conduct ethics training minimally every quarter in which new employees are hired
• Evaluate the thoroughness and effectiveness of the laboratory’s training program
• Perform system audits of each department, write audit reports, and approve audit responses
• Perform data audits
• Perform special audits as deemed necessary by data audits, client inquiries, etc.
• Conduct and respond to external audits conducted by clients and regulatory agencies
• Work with management in performing annual Management Review of the Quality System
• Assist in reviewing and/or writing of Quality Assurance Project Plans, and technical and
• QC specifications in contracts and proposals.
• Maintain all necessary laboratory certifications
• Manage scheduling, ordering, login, and reporting of PT samples
• Monitor new regulations, communicate them to the laboratory, and ensure compliance with the current version of regulations
• Review and approve laboratory SOPs. Write SOPs as needed
• Maintain historical indices of all technical records (e.g. SOPs, audits, ancillary equipment calibration, logbook distribution, etc.)
• Assist in and monitor laboratory’s compliance with the reference methods, SOPs, and agency-specific requirements
• Maintain training records, including Demonstrations of Capability (DOCs) for all analysts
• Assist in identification of systematic problems within the laboratory. Perform root cause analysis investigations in response to audit findings, client complaints, training needs assessments, data recall events, etc. Recommend resolutions for ongoing or recurring nonconformance, and ensures implementation of appropriate corrective action
• Track revised reports, and assist in identifying systematic improvements to minimize errors
• Track customer complaints and assists in identifying improvements
• Oversee and approve method detection limit (MDL) studies and verifications
• Generate and submit monthly QA reports
• Participates on QA conference calls
• Oversee generation of control charts and control limits, update of reference tables
• Perform or arrange for calibration of laboratory support equipment which may include balances, weights, and thermometers
• Assist other laboratories as needed, including performing systems audits of other Eurofins Environment Testing laboratories
• Act as the QA representative and a representative of senior management in client meetings, regulatory meetings, open forums for discussing regulation changes, etc.

Qualifications

• BS/BA in Chemistry/Sciences from an accredited university
• Minimum 5 years bench level analytical experience plus formal QA training or 2 years QA experience. 
• Authorization to work in the United States indefinitely without restriction or sponsorship

The ideal candidate would possess:

• Environmental methodologies
• General regulatory requirements
• Analytical laboratory techniques
• Laboratory QA requirements
• Statistical principles
• Knowledge of computers, spreadsheets, and databases
• Computer skills and databases
• Experience with technical writing
• Time management and problem solving skills
• Ability to communicate effectively at all levels of organization, clients and outside agencies
• Analyze problems and effect solutions
• Ability to prioritize
• Strong computer, scientific, 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
• Strong leadership, initiative, and teambuilding skills

Additional Information

We support your development! Do you feel you don’t match 100% of the requirements? Don’t hesitate to apply anyway! Eurofins companies are committed to supporting your career development.

We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique.

Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal!

Find out more in our career page: https://careers.eurofins.com/

Company description:

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 discovery pharmacology, forensics, advanced material sciences and agroscience contract research 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 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 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.

In 2022, Eurofins generated total revenues of EUR 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.

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

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

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
 
Eurofins Environment Testing Businesses in the US are routinely engaged in Federal Contracts. Federal Government vaccination mandates may apply to staff working in these businesses. Successful applicants may be required to confirm vaccination status or demonstrate eligibility for medical or religious exemptions prior to commencing employment.  In addition, certain positions require travel for which vaccination is required in accordance with Eurofins policy.