Test and troubleshoot PCR assays for theBAX® System, and consumables and reagents for the Riboprinter®- an automated Southern blotting system used to characterize and identify bacteria. Responsible for supporting manufacturing through implementation of process improvements.
Responsible for wide range of microbiological and/or molecular-based tasks including use of aseptic techniques, making media, propagation and enumeration of bacterial cultures, polymerase chain reaction, Southern blotting, and DNA purification and quantification.
Responsible for troubleshooting non-conforming products to identify root cause. Implement corrective and preventive actions to resolve problems and drive continuous improvement.
Essential functions of the job are listed below. Other responsibilities may also be assigned. Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.
- Carry out laboratory procedures, including but not limited to polymerase chain reaction (PCR), culture of pathogenic bacteria, preparation of culture media and reagents, DNA purification and quantification, Southern blotting,
- Document all data and prepare written summaries of work completed
- Provide technical review of operating procedures for the manufacturing team
- Assist with other lab maintenance tasks
- Ensures compliance with and/or follows all organizational systems, programs, training, policies, and procedures as required and complies with relevant legal mandates. Seeks guidance as necessary.
- Actively supports and participates in the safety program, both for self-protection and the protection of other employees, by reading and abiding by all requirements in the Safety Manual
- Carries out all responsibilities in an honest, ethical and professional manner.
- Must be able to fulfill essential job function in a consistent state of alertness and safe manner.
- Handles various other duties as delegated by Manager
The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position. Please note that the minimum qualifications may vary based upon the department size and/or geographic location.
- Bachelor’s Degree in Microbiology, Molecular Biology, or a related field required.
- Minimum of 2 years of experience required that includes the following:
- Working in an ISO 9001-compliant Quality Management System (knowledge of GMP is a plus)
- Experience with change control processes, non-conformances and deviations, root cause investigations, and implementation of corrective and preventive actions
- Hands on experience with microbiological and molecular biology techniques, including:
- Polymerase Chain Reaction (PCR)
- Southern Blotting
- Propagation and enumeration of bacterial cultures
- Media and reagent preparation
- Aseptic technique
- Six Sigma experience is a plus
- Intermediate knowledge of Microsoft Office (Outlook, Word, Excel, Visio, PowerPoint) and Adobe Acrobat required.
- Excellent verbal and written communication,
- Must be able to use discretion and independent judgment.
- Must be able to work in a team environment.
- Must be able to pay close attention to details.
- Must be able to adapt and flex to a changing environment.
- Must be able to lift/carry 20 pounds.
- May occasionally be required to travel.
- May occasionally work evenings and/or weekends.
In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.
- This position is considered light work – exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.
- Required to have close visual acuity to perform an activity such as: viewing a computer screen
- Frequently required to maintaining a static position, talking, hearing, seeing and repetitive motions.
In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.
- The work environment includes both a typical office environment and a laboratory environment, including exposure to Biosafety Level 2 pathogens.
Reporting to: Scientific QA Manager
FLSA Status: Exempt
Disclaimer: This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the job. 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. This job description does not constitute a contract of employment and that the company may exercise its employment-at-will rights at any time.