Quality Assurance Group Leader

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 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.  
• 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 :

• Bachelors 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 including:

• 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.

Remote Work :

No

Employment Type :

Full-time