Quality Assurance Group Leader

Eurofins USA BioPharma Services•Lancaster, PA

1d•Onsite

About The Position

Eurofins Scientific is an international life sciences company providing a unique range of analytical testing services across multiple industries to ensure products are safe, ingredients are authentic, and labeling is accurate. The Eurofins network is a global leader in food, environment, pharmaceutical, and cosmetic product testing, as well as agroscience Contract Research Organisation services. With a presence in over 54 countries and a portfolio of over 200,000 analytical methods, Eurofins evaluates the safety, identity, composition, authenticity, origin, traceability, and purity of biological substances and products. This role involves leading a Quality Assurance team, ensuring quality data is provided to clients in a timely manner, and supporting various quality initiatives within the laboratory.

Requirements

Familiarity with cGMP Quality Systems (21 CFR Part 210, 211, EU GMP Annex)
Strong computer, scientific, and organizational skills
Ability to multitask and 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.
Prioritize employee development through cross-training, technical skills development, and clear communication of expectations and goals.
Coach direct reports through challenges, providing constructive and real-time feedback for continuous improvement.
Interact with and educate other departments (technical and support) to ensure quality data delivery that meets client needs.
Demonstrate professional behavior and support upper management in initiatives to improve quality and productivity.
Collaborate with laboratory and support groups to improve quality metrics and enable CAPA implementation.
Support technical and support groups with investigation writing and review, including thorough root cause analysis.
Perform technical writing and review, track action items, and drive them to completion.
Identify trends in recurring events.
Demonstrate leadership qualities such as effective communication, confidence, motivation, and follow-through.
Perform higher-level QA tasks including 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, and review/write QAU procedures.