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Senior Lab Manager
Job Description
- Lead a team of QC microbiology professionals, ensuring technical precision and quality in all lab operations including sample management, testing schedules, microbial isolation, equipment maintenance, and inventory control.
- Provide mentorship and guidance to foster a culture of continuous improvement and excellence among staff.
- Serve as the primary contact and subject matter expert (SME) for customer inquiries regarding testing services.
- Oversee and perform routine QC testing such as bioburden, endotoxin, B&F testing, microbial ID analysis, preservative efficacy, and raw materials testing.
- Plan and manage water and environmental monitoring sampling in alignment with testing and manufacturing activities.
- Implement corrective actions in response to environmental monitoring excursions.
- Develop, maintain, and review QC testing procedures, including the creation and oversight of SOPs, protocols, and reports according to ISO 13485 QMS.
- Ensure compliance with Good Manufacturing Practices (cGMP) in all documentation and testing processes.
- Lead continuous improvement initiatives and ensure the QC team meets KPIs.
- Play a key role in preparing for and participating in regulatory inspections.
- Ensure data traceability and accuracy throughout the testing process, acting as the final sign-off for assigned studies.
- Stay current with applicable regulatory requirements (GMP, GLP, ISO, etc.) and company policies.
- Ensure analysts follow approved test procedures, accurately record data, and take corrective actions when needed.
- Collaborate with sponsors, providing timely testing updates and ensuring their expectations are met.
- Work with cross-functional teams, including Quality Assurance and Sales, on testing quotes and organizational goals.
- Ensure that analysts are properly trained in the necessary testing procedures.
Job Requirements
- Extensive experience in microbiology, with a focus on pharmaceutical, biotechnology, or medical device products.
- Proficient in laboratory testing, equipment management, and quality control.
- Strong leadership experience in a QC laboratory setting.
- Ability to troubleshoot, solve problems, and make informed decisions.
- Excellent attention to detail, documentation skills, and proficiency in Microsoft Office and lab systems.
- Strong communication skills, both verbal and written.
- Exceptional organizational skills with the ability to manage multiple tasks and meet deadlines.
- Operates in a professional lab setting, using standard office and laboratory equipment (e.g., microscopes, pipettes, computers).
- Occasional local or overnight travel may be required.
- Regular movement throughout lab and office areas, including standing, bending, and using various lab tools.
- Must be able to wear appropriate personal protective equipment (PPE) such as lab coats, goggles, gloves, and face shields as required.
- Bachelor’s degree in Biology or a related field.
- 5-10 years of experience in ISO 17025/13485 Microbiology laboratory settings in a technical management role.
Meet Your Recruiter
Erin Hoke
My career began in the hospitality industry, but I sought a change for better work-life balance and family considerations. I moved into the world of recruiting in 1999, I started in light industrial roles and gradually specialized in contract and permanent placements across a wide range of technical industries.
In 2006, I co-founded Recruiting Resources with my father, focusing on professional services and human resources staffing for both small and national companies. In 2011, I became an independent recruiter, partnering with a small Firm in the Maryland area where I concentrated on sourcing talent primarily for the Life Sciences industry but also expanded into non-technical areas.
Throughout my career, I have valued personal connections and helping individuals find positions that align with their expertise and lifestyle. My journey reflects adaptability, entrepreneurship, and a passion for facilitating meaningful career opportunities for others. I joined Lloyd Staffing in Aug 2024 to specialize again in Life Sciences.
In my free time, I spend most of my time with my son. We have become quite the fishermen over the past 5 years.
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