The Quality Control Supervisor, Microbiology is responsible for
overseeing the daily operations of the microbiology and
environmental monitoring testing programs at the company to ensure
compliance with cGMP standards. This position will directly
supervise a team of QC analysts, and will interact extensively with
other department supervisors, quality personnel, manufacturing
personnel, and business partners. This person will also be
responsible for development, transfer and validation of microbial
Oversees the work of QC analysts that contribute to the
Supervisor’s area(s) of functional responsibility, ensuring all
work is completed properly and in a timely manner. Provides input
and feedback to other supervisors for ongoing development of
employees and towards annual performance assessments.
Provides direct supervision of one or more junior level QC
analysts, assuming primary responsibility for communication of
requirements and expectations of the employee’s daily job. Will
perform all aspects of a supervisor’s role including hiring,
coaching, developing, providing regular feedback to employee about
his/her performance, and managing performance or behavioral
Manages Microbiology (Environmental Monitoring and utilities)
related sampling and testing of in-process and lot release samples.
Functional area oversight requires assuring that relevant
deliverables are provided on time to support corporate, CMC, and
departmental goals. Will also be responsible for assuring that
analysts are trained on the relevant equipment and methodology,
assuring equipment is maintained and used properly, providing first
line troubleshooting as needed, and reviewing related Quality event
records (e.g., Deviations and CAPAs).
Assists in designing and continuously improving Quality Control
systems, particularly within areas of microbiology.
Writes and reviews departmental and interdepartmental SOPs
covering microbial methods and general policies.
Reviews, analyzes and trends microbial data that may include EM,
in-process, lot release, and/or stability related microbial
testing. Regularly review failure trend data within assigned
functional area, and be responsible for investigation of out of
Responsible for developing, establishing, transferring, and
validating microbial testing methodology.
Education, Experience, & Credentials
High School Diploma and minimum of 10 years of direct related
experience, plus minimum of 2 years of supervisory experience.
Bachelor’s Degree in a scientific discipline and minimum of 6
years of experience, plus at least 2 years prior experience
coaching and mentoring junior level laboratory personnel.
Significant experience in a GMP or GLP testing environment.
Prior experience providing oversight of a cleanroom microbial
area of expertise, such as environmental monitoring or utilities
Experience working on extremely complex problems in which
analysis of situation or data requires an in?depth evaluation of
Knowledge, Skills and Abilities
Ability to act independently to determine schedules, methods and
procedures on new assignments
Possesses the confidence to exercise independent judgment in
developing methods, techniques, and evaluation criteria for
Able to handle multiple priorities in a fast-paced
Excellent written and verbal communications skills
Demonstrated ability to manage conflict and bring resolutions to
technical problems and human interaction issues that arise
Broad knowledge base of cGMP requirements for quality control
Flexibility and adaptability to facilitate the movement into
different areas of QC
Proficient in the use of Microsoft or equivalent software; word
processing, email, spreadsheet or other analysis tools, database,
Will directly supervise the activities of 2-5 lower-level
In over 25 years of placing the right professionals in the right
jobs, Germer International has earned the trust of hundreds of
Pharmaceutical, Biotech, and Medical Device companies, attracting
the best qualified candidates.
1777 Sentry Parkway | Blue Bell PA 19422