Microbiology Supervisor (QC Lab)

Merck Group • $85K — $136K *
Saint Louis, MO 63129In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Microbiology, Biochemistry, Biology, or a related Life Science discipline.
  • 3+ years of experience in a quality control role, preferably as a supervisor or manager.
  • In-depth knowledge of FDA and EMA regulations for pharmaceutical manufacturing and microbiological testing requirements.
  • Proficiency in analytical instrumentation and laboratory software.
  • Comprehensive knowledge of ICH Q7, 21 CFR 210/211, and related pharmacopeia guidelines.

Responsibilities

  • Supervise and develop a QC Microbiology team of 8-10 employees, ensuring accountability for quality performance metrics.
  • Oversee Environmental Monitoring and Bioburden/Endotoxin Testing laboratories to ensure compliance with standards.
  • Manage laboratory testing schedules to guarantee timely product releases.
  • Establish and implement quality systems and standards to drive continuous quality improvement initiatives.
  • Participate in client and regulatory audits, supporting compliance efforts.
  • Communicate regularly with internal and external customers to update on project status and resolve issues.
  • Perform additional duties as assigned by management.

Benefits

  • Health insurance.
  • Paid time off (PTO).
  • Retirement contributions.
  • Additional perquisites as offered by the company.
Full Job Description
Your Role

The Microbiology Supervisor leads the GMP Quality Control Microbiology department, ensuring full compliance with ICH Q7 and 21 CFR regulations for active pharmaceutical ingredient (API) testing. Key responsibilities include overseeing microbiological test methods, method validations, and tech transfers; managing OOS/OOT investigations, deviations, and CAPAs; and conducting routine training on aseptic techniques and testing procedures.

  • Supervise, manage, and develop a QC Microbiology team of 8-10 employees, holding full accountability for meeting business quality performance metrics and KPIs
  • Oversee the Environmental Monitoring Program and the Bioburden and Endotoxin Testing laboratories
  • Manage and prioritize laboratory testing schedules to ensure all products are released in a timely manner
  • Develop and implement programs to establish and maintain quality systems and product/service standards, while driving quality improvement initiatives and establishing policies, procedures, and methods to enhance product, material, component, process, and operational quality
  • Support and participate in client and regulatory audits
  • Interface with internal and external customers on a regular basis to communicate project status, resolve issues, and implement methods, techniques, and evaluation criteria for products and processes
  • Perform other duties as required by management


Who You Are

Minimum Qualifications:

  • Bachelor's Degree in Microbiology, Biochemistry, Biology, or other Life Science discipline
  • 3+ years of experience as a quality control manager, supervisor, or lead


Preferred Qualifications:

  • Master's degree in a Life Sciences discipline
  • Experience as a Quality Control Supervisor or Manager at a Life Sciences organization
  • In-depth knowledge of health authority (FDA, EMA) expectations for pharma/biotech bulk and finished product manufacturing, alongside microbiological testing requirements
  • Proficiency with analytical instrumentation and laboratory software
  • Comprehensive knowledge of ICH Q7, 21 CFR 210/211, USP, and EP pharmacopeia requirements
  • Proven experience working in a highly matrixed organization, preferably within a GMP manufacturing environment
  • Strong written and verbal communication skills, with a demonstrated ability to translate complex issues into straightforward, succinct explanations
  • Advanced root cause analysis and problem-solving skills
  • Strong computer skills, including proficiency in word processing and Quality Systems databases
  • Subject matter expertise in aseptic principles and practices
  • Strong understanding of microbiological methodology and laboratory techniques, specifically USP , USP , and USP


RSREMD

Salary range for this position: $85,500 - $136,000 annually

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

Explore Job Opportunities and Growth

Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

Internship Programs

Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

Inclusive Culture and Leadership

Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

Networking and Professional Development

Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

Stay Connected with Merck Group Careers

Interested candidates can explore open positions that match their skills and interests through the Merck Group careers page. The company values curious, creative, and solution-driven team players who are eager to make an impact.

Keep Up to Date

Stay informed with career tips, insider perspectives, and industry-leading insights from Merck Group professionals. These resources are invaluable for those looking to advance their careers and stay ahead in a competitive job market.

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READ CAREERS BLOG

Merck Group is continuously looking for individuals who are ready to drive innovation and lead in the global marketplace. Whether through full-time positions, internships, or leadership roles, Merck Group offers a career path filled with opportunities for growth, learning, and leadership.
Learn more about Merck Group
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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