Description

The QC Microbiology/EM Laboratory Manager oversees Quality Control Microbiology and Environmental Monitoring (EM) testing labs, ensuring compliance with quality system requirements (e.g., QSR, ISO9001/ISO13485) in a fast-paced, FDA-regulated Medical Devices/Diagnostics environment. This role requires 100% on-site presence.

Key Responsibilities:

Laboratory Management: Oversee microbiological and EM testing, including growth performance, antimicrobial neutralization, contamination checks, bioburden, and environmental monitoring of water, surfaces, air, and cleaning.Supply Chain Management: Manage lab supplies, monitor costs, and coordinate with suppliers to ensure inventory replenishment and avoid expiry.Team Development: Develop employees according to the site competency framework, ensuring accountability for performance, metrics, and projects.Quality Initiatives: Lead quality initiatives to improve processes, efficiency, reliability, and accuracy of testing.Leadership: Model company principles, lead strategy implementation, set team objectives, and communicate progress. Manage and develop personnel, inspire top performance, and promote growth.

Primary Responsibilities:

Ensure compliance with procedures and GDP requirements.Maintain laboratory equipment and supplies.Monitor lab supply costs and reduce consumables cost.Develop realistic plans to address supply chain issues.Track laboratory supply expenditures and usage.Ensure team accountability and engagement.Lead cross-functional activities and audits (e.g., MDSAP, FDA, ISO).

Skills and Qualifications:

Strong knowledge of EM and microbiological laboratory testing.Ability to make sound decisions and manage resources effectively.Excellent leadership and communication skills.Proficiency in using tools and technologies for tracking and reporting.

Additional Skills & Qualifications

Bachelor’s degree with 5 years of experience in a regulated laboratory environment, Environmental Monitoring and Microbiology is requiredMinimum 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).

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 19, 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 & Inclusion

At 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 people

The 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.