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QC Microbiology Analyst III
2 months ago
QC Microbiology Analyst III
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 Quality Control Microbiology Analyst III serves as a support role to clinical and/or commercial production. The QC Microbiology Analyst will coordinate data for batch release, participate in project/client meetings, and author/revise environmental monitoring procedures. Additionally, the QC Microbiology Analyst will perform environmental monitoring activities including, but not limited to, non-viable particulate testing, active air viable, passive air viable, surface viable, and personnel monitoring.
Essential Functions and Responsibilities
Below is the summary of the role responsibilities. This is not an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.
Under the direction of the Supervisor of QC Microbiology, responsibilities of the QC Microbiology Analyst III will include but are not limited to:
Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
Coordinates data for batch release
Participation in project/client meetings and communications, providing scientific and technical expertise
Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols
Review of investigations and documentation of non-confirming events and environmental excursions.
Apply expertise of compliance requirements to maintain an inspection-ready state.
Participate and act as subject matter expert during audits/inspections
Develop and train QC Microbiology Analyst II on relevant business processes
Processing of purchase orders for outsourced testing and lab supplies
Coordinates work orders
Other duties as assigned
Qualifications
BA/BS in a science or relevant field required or equivalent experience
Minimum 5-7 years of experience with environmental monitoring within the biopharmaceutical industry
Strong knowledge of FDA and EU regulatory standards. cGMP experience required.
Strong knowledge of microbiological test methods and philosophies.
Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.
Competencies/Candidate Profile
Proficient with computer software such as
Microsoft Office
MODA/LIMS
Microsoft Visio (preferred)
Netsuite (preferred)
Maximo Asset Management System (preferred)
Proficient knowledge of ISO and EU standards
Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review.
Strong written and oral communication skills
Strong technical writing skills
Technical training experience
Must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities
Supervisory Responsibility
N/A
Quality Requirements
Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
Attend all required Quality & Compliance training at the specified interval.
Minimum Required Training to be Completed within the First 90 Days of Hire
GxP/GDP Training as assigned
Aseptic Processing Standards
The employee must be able to comply with the company’s personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification as well as annual re-qualification as a core competency requirement of their employment in this role.
Working Environment
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.
Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.
Must have the ability to observe staff in a cleanroom environment for a period of time.
Must be able to work in a team-oriented environment.
Must have the ability to work with specialized equipment.
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.
Physical Requirements
The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully.
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 hear.
Must be able to exchange information in person, on the telephone, and to make presentations.
Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
Sunday-Thursday, 1st Shift (8:30 - 5:00PM).
