Pay Range:

Position Summary:

The Supervisor, QC Microbiology is a hands-on, working supervisor who leads and actively participates in daily laboratory operations, including routine microbiological testing and environmental monitoring. This role is responsible for ensuring the timely and compliant execution of testing, data review, and lot disposition in accordance with SOPs and approved specifications.

In addition to providing direct laboratory support, the supervisor leads the QC Microbiology team by driving a culture of ownership, accountability, and collaboration. This position also plays a key role in supporting investigations (e.g., OOS and contamination events) and partnering cross-functionally to achieve operational and quality objectives.

Key Responsibilities:

Team Leadership & Working Supervision

• Serve as a hands-on (working) supervisor, actively performing and supporting microbiological testing alongside team members as needed

• Supervise daily laboratory operations, including staff scheduling, workload balancing, and priority setting

• Provide real-time coaching, technical guidance, and issue resolution

• Foster a culture of high ownership, accountability, and collaboration within the team

• Lead by example in work ethic, data integrity, and compliance

Testing, Validation & Compliance

• Perform and oversee microbiological testing, including:

  • Bioburden testing

  • Sterility testing

  • Environmental monitoring

• Support and/or lead method validations, including compendial (USP) and internal methods

• Support equipment qualification and validation activities (IQ/OQ/PQ) for lab equipment

• Review data and make lot disposition decisions in accordance with approved specifications

• Ensure all laboratory activities comply with SOPs and internal quality standards

• Lead and support OOS, deviation, and contamination investigations, including root cause analysis and CAPA development

• Ensure accurate, complete, and inspection-ready documentation

Cross-Functional Collaboration

• Coordinate closely with Operations, Development, Product Support, and Technical/Customer Services to support testing needs and timelines

• Proactively communicate status updates, risks, and issues to management and stakeholders

• Promote a collaborative approach to problem-solving across departments

Laboratory Systems & Continuous Improvement

• Maintain and improve SOPs, test methods, and controlled documentation

• Identify and implement improvements to increase efficiency, reduce errors, and enhance compliance

• Track and trend key quality metrics (e.g., OOS, contamination events, turnaround time, productivity)

• Drive continuous improvement initiatives within the lab

Equipment & Laboratory Management

• Ensure timely calibration, maintenance, and qualification of laboratory equipment

• Maintain service schedules and ensure equipment is fit for use

• Ensure laboratory organization, cleanliness, and safety standards are consistently met

Training & Staffing

• Participate in hiring, onboarding, and training of new team members

• Maintain training curricula and ensure training compliance (e.g., ComplianceWire)

• Provide ongoing development, coaching, and performance feedback

• Conduct performance evaluations and support goal setting

Additional Responsibilities

• Support departmental and company initiatives related to productivity, quality, and operational excellence

• Perform additional duties as assigned

QUALIFICATIONS

Education and Experience:

• Bachelor’s or Master’s degree in Microbiology, Molecular Biology, Biotechnology, Biochemistry, or related field

• 4+ years of relevant experience with a Bachelor’s degree, or

• 1+ year of relevant experience with a Master’s degree

• Prior leadership or informal leadership experience preferred

Knowledge, Skills, and Abilities:

• Strong hands-on experience with Bioburden testing, sterility testing, and environmental monitoring programs

• Experience with method validation, including compendial (USP) and internal methods

• Experience supporting or executing equipment qualification/validation (IQ/OQ/PQ)

• Experience investigating Out-of-specification (OOS) results & contamination events

• Knowledge of QC laboratory systems, SOPs and controlled documentation, deviations and CAPA processes, & method validation and lifecycle concepts

• Demonstrated ownership mindset with the ability to drive accountability in self and others

• Strong collaboration skills with ability to work effectively across teams

• Effective leadership and coaching abilities in a fast-paced environment

• Strong organizational and time management skills

• Analytical problem-solving skills with attention to detail

• Ability to manage multiple priorities while maintaining quality and compliance

• Proficiency in Microsoft Office applications

Working Conditions:

• Work performed in a laboratory and production environment with exposure to chemicals, reagents, and standard lab equipment.

• Standard schedule hours with occasional variation depending on production needs.

• Minimal or no travel required.

Physical Requirements:

• Ability to lift and handle materials weighing 5–50 lbs.

• Ability to stand, walk, and perform repetitive laboratory tasks for extended periods.

• Manual dexterity required for laboratory equipment and fine measurement techniques.