Description
The QC Microbiology/EM Laboratory Manager provides direct oversight and guidance in the Quality Control Microbiology and Environmental Monitoring (EM) testing laboratories, including applicable support and storage areas, to ensure manufactured products are appropriately measured and monitored according to quality system requirements (e.g., QSR and ISO9001/ISO13485).
This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. QC Microbiology/EM Laboratory Manager is a key position with expected knowledge and comprehension of subject matter related to EM and microbiological laboratory testing. They are responsible for ensuring microbiological and EM testing is performed in compliance with procedures and GDP requirements including growth performance, antimicrobial neutralization and contamination checks, bioburden and environmental monitoring sampling/testing of water, surface, air, and cleaning. This position requires a 100% on site presence.
Skills
Microbiology, lab management
Additional Skills & Qualifications
Bachelor’s degree with 5 years of experience in a regulated laboratory environment, Environmental Monitoring and Microbiology is required
Minimum of 2-3 years of supervisory experience required, GMP environment preferred.
Experience in managing a department budget and maintaining laboratory supply inventories at a department level.
Demonstrates in-depth technical and scientific knowledge with a working knowledge of relevant laboratory techniques and quality principles (GMP/GLP). Specific experience with microbiological/EM testing.
Experience in the use of software tools for data entry and analysis (LIMS) and proficiency working with Microsoft Office Suite (e.g., Excel, PowerPoint, Outlook, Word).
Able to demonstrate experience in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g., ISO, QSR, FDA.). Has knowledge of USP and EP/BP method/validation regulations.
Experience in supporting regulatory audits (e.g., FDA, MDSAP, ISO, OSHA, EPA).
Experience Level
Expert Level
Pay and Benefits
The pay range for this position is $50.00 - $65.00
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Durham,NC.
Application Deadline
This position will be accepting applications until Dec 18, 2024.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.