Quality Assurance Group Leader

EurofinsLancaster, PA
Onsite

About The Position

Eurofins Scientific is an international life sciences company providing analytical testing services across multiple industries to ensure products are safe, healthier, and more sustainable. The Eurofins network is a global leader in various testing and laboratory services, including food, environment, pharmaceutical, and cosmetic product testing, as well as agroscience Contract Research Organisation services. With a vast network of laboratories across numerous countries, Eurofins offers a comprehensive portfolio of analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability, and purity of biological substances and products. This role involves leading a Quality Assurance team, delegating responsibilities, providing support and feedback, and prioritizing employee development through cross-training, technical skills enhancement, and clear goal communication. The Quality Assurance Group Leader will coach direct reports through challenges, offer constructive feedback for continuous improvement, and interact with other departments to ensure the delivery of quality data that meets client needs. The position also requires demonstrating professional behavior, supporting management initiatives for quality and productivity improvements, and collaborating with laboratory and support groups to enhance quality metrics and implement CAPA. This includes supporting investigation writing and review, performing root cause analysis, tracking action items, identifying trends, and conducting higher-level QA tasks such as major investigation writing/review, in-depth root cause analysis, data trending/analysis, supplier and internal audits, validation/change control, batch record/EM report review, assisting with agency inspections, and reviewing/writing QAU procedures.

Requirements

  • Familiarity with cGMP Quality Systems (21 CFR Part 210, 211, EU GMP Annex)
  • Strong computer, scientific, and organizational skills
  • Ability to Multi-task and to make decisions when required.
  • 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 team building skills
  • Bachelor’s degree in Biology/Chemistry with a minimum of 2-3 years experience in the laboratory or a minimum of 4-5 years of experience in the laboratory at a high level of performance (if possessing no degree)
  • Experience in regulated industries (Pharmaceuticals, Medical Device) Biologics)
  • Authorization to work in the United States indefinitely without restriction or sponsorship

Responsibilities

  • Delegate responsibilities and project ownership to direct reports.
  • Provide follow-up, support, and constructive feedback for delegated tasks.
  • Make employee development a top priority – project/department cross training, technical skills development, involvement/ownership, job plans in place, expectations/goals clearly communicated.
  • Be available and coach direct reports though challenges, without doing the work for them.
  • Provide direct reports with constructive, positive feedback for continuous improvement and development.
  • Provide real-time feedback.
  • Interact with and/or educate other departments (technical and support) to ensure that Eurofins, as an organization, is providing quality data in a timely manner that meets the clients needs.
  • Demonstrate professional behavior and support upper management in initiatives to improve quality/productivity.
  • Work with the laboratory and support groups to improve quality metrics, and enable CAPA implementation.
  • Support the technical and supports groups with investigation writing and review, including thorough root cause analysis.
  • Technical writing and review; tracking action items and driving to completion; ability to identify trends in recurring events.
  • Demonstrate leadership qualities such as: effective communication, display of confidence, motivation, and follow through on assignments.
  • Perform higher level QA tasks including but not limited to: major investigation writing/review, in-depth root cause analysis, data trending/analysis, supplier audits, internal audits, validation/change control writing/review, batch record/EM report review, assist with agency inspections, review/write QAU procedures.

Benefits

  • Comprehensive medical coverage
  • dental
  • vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation
  • holidays
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