Quality Assurance Group Leader

Eurofins BioPharma Product Testing North America; Lancaster (Lancaster County); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA BioPharma Services in Lancaster, PA seeks a QA leader to drive high-quality data and regulatory compliance. You will manage investigations, perform root cause analysis, and coach the QA team to maintain cGMP standards across laboratory operations.

Position is full-time, Mon-Fri, with overtime as needed. Requires a biology/chemistry degree or equivalent lab experience and authorization to work in the United States without sponsorship.

Qualifications

• Bachelor’s degree in Biology/Chemistry with 2-3 years lab experience, or 4-5 years lab at a high level (no degree)
• Experience in regulated industries (Pharmaceuticals, Medical Device, Biologics)
• Authorization to work in the United States indefinitely without sponsorship
• Familiarity with cGMP Quality Systems (21 CFR Part 210, 211, EU GMP)

Responsibilities

• Lead investigations and write/review major QA reports
• Perform root cause analysis and data trending
• Coordinate supplier and internal audits and CAPA
• Review/write QAU procedures and change controls
• Provide guidance to direct reports and improve quality metrics

Skills

cGMP Quality Systems

Communication

Multi-tasking

Attention to detail

Independent work

Leadership

Education

Bachelor’s degree in Biology or Chemistry

4–5 years high-level laboratory experience (no degree)

Job 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 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.

Job Description

Employee 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 through 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.
• Also 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.

Qualifications

The ideal candidate would possess

• 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

Basic Minimum Qualifications

• 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 degreee)
• Experience in regulated industries (Pharmaceuticals, Medical Device) Biologics)
• Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

Position is Full-time, Monday-Friday, 8:00 a.m.-5:00 p.m., with overtime as needed. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply.

Excellent full-time benefits include:

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

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.