Supervisor, QC Microbiology
Company: Minaris Regenerative Medicine
Location: Mountain View
Posted on: January 12, 2022
At Minaris Regenerative Medicine our vision is creating future
cell therapy miracles together. We are a leading global contract
development and manufacturing organization dedicated to the
advancement of cell and gene therapy products. We believe in the
transformative potential of cell and gene therapies and we are
shaping the future of medicine. We open doors in the regenerative
medicine industry for those looking to transform medicine while
continuously improving an innovative, growing company.
The Supervisor, QC Microbiology organizes, and directs staff to
meet and exceed cGMP requirements, establish KPIs, while adhering
to quality control-microbiological and technical standards.
Provides oversight of day to day activities including adjustment of
workflow, test performance, and quality compliance.
Essential Functions And Responsibilities
Investigate and document non-confirming events and environmental
Troubleshoot and recommend process improvements to achieve greater
efficiency ad meet quality goals.
Interact with other the EM/Microbiology departments on a regularly
scheduled basis to discuss and harmonize best practices, procedures
and processes between the sites.
Participate in department and cross functional meetings.
Ensure compliance with regulatory agency requirements by enforcing
a quality culture throughout the department.
Interact with internal and external customers to ensure proper
sampling, reporting, and resolution of questions and concerns.
Author and revise Standard Operating Procedures, Work Instructions,
forms and Protocols to reflect current practices.
Perform microbiological and environmental monitoring data review.
Compile and issue quarterly and annual Environmental Monitoring
Provide staff development through feedback aimed towards
performance development and review.
BS in Microbiology or relevant field required.
Biotechnology Certificate and/or cGMP experience
Minimum of 3 years of experience with environmental monitoring or
within the biopharmaceutical industry.
Strong knowledge of microbiological test methods, philosophies,
method validation and method transfer.
Strong knowledge of quality systems and ability to interpret
Quality standards of implementation and review.
Proficient with computer software with MS Office, Excel, and
Adapts to changing business needs, conditions and works with
variety of situations, individuals, groups, and varying client
Ability to remain focused and effective in high stress
Builds constructive working relationships characterized by a high
level of acceptance, cooperation, and mutual respect.
Able to handle challenging interpersonal relationships.
Carries out supervisory responsibilities in accordance with the
organization's policies and applicable laws.
Responsibilities include interviewing, hiring, and training
employees; planning, assigning, and directing work; appraising
performance; rewarding and disciplining employees; addressing
complaints and resolving problems for the following positions.
Directly supervised the following roles:
QC Microbiology Associate
Minimum Required Training
While performing the duties of this job, the employee may
occasionally be exposed to infectious diseases transmittable
through human blood, tissues, or bodily fluids and are expected to
utilize universal precautions with all human specimens. Other
exposures may include gases (nitrogen), or corrosive chemicals
(Clorox, potassium hydroxide)., or exposure to liquid nitrogen. The
noise level in the work environment is moderately noise.
This role operates within a professional office environment of a
manufacturing operations plant. This role routinely uses standard
office equipment such as computers, phones, photocopiers, filing
cabinets and fax machines. Seating is mixed and includes open space
seating, cubicle, and office space. Noise level is moderate.
Must have ability to work in a team-oriented environment and with
Must utilize proper personal protective equipment (PPE) when
handling all human specimens, gases, corrosive chemicals, and
Must have the ability to work in the cleanroom environment for
extended period of time
Must have the ability to work with specialized equipment
Must be able to handle the standard/moderate noise of the
Aseptic Processing Standards
The employee must be able to comply with company's personal hygiene
standards as they apply to aseptic processing. The employee must
successfully complete sterile gowning training/qualification and
aseptic process qualification (personal media fill) as well as
annual/semiannual re-qualification as a core competency requirement
of their employment in this role.
An individual may exert up to 10 pounds of force occasionally or a
negligible amount of force frequently to lift, carry, push, pull,
or otherwise move objects
Must be physically capable to stand, walk, sit, bend, stretch, use
hands to handle or feel, reach with hands and arms, and talk or
The employee is frequently required to lift and/or move up to 30
pounds and occasionally move tanks up to 300 pounds (with
Heavy cryo-gloves must be used when working with liquid
QC Microbiology Associates
Please note this job description is not designed to cover or
contain a comprehensive listing of activities, duties, or
responsibilities that are required of the employee for this job.
Duties, responsibilities, and activities may change at any time
with or without notice.
Monday-Friday, 1st Shift (8:30-5:00PM)by Jobble
Keywords: Minaris Regenerative Medicine, Mountain View , Supervisor, QC Microbiology, Other , Mountain View, California
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