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Microbiologist

Title: Microbiologist Status: Exempt
Reports to: Quality Control Manager Supervises: N/A
About Imprimis Pharmaceuticals
ImprimisRx is one of the nations leading ophthalmology compounding businesses ImprimisRx is headquartered in San Diego, CA and operates two production and dispensing facilities based in Ledgewood, New Jersey. ImprimisRxs 503B outsourcing facility produces formulations for office use in accordance with current good manufacturing practices (cGMP), the highest federal quality standards for drug manufacturers in the country. Its 503A pharmacy produces customizable, patient-specific formulations pursuant to a physician prescription for several chronic care needs. There have been over one million eyes served by the formulations produced at these facilities.
Job Summary
Under the leadership of the Quality Control Manager, the Microbiologist is responsible for performing in-process and finished product release testing. The position requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of microbiology and laboratory instrumentation. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success. Ensures test methods are qualified/validated and performed under cGMP requirements. Performs a variety of duties related to the efficient and effective functioning of a Quality Control lab. Assists in reviews modifies SOPs and other lab documents as necessary.
Position Responsibilities:
Perform Microbiological testing and method validations related to:
USP 71 Sterility
Kinetic/chromogenic Endotoxin assay
This position will also be a backup for viable and non-viable environmental monitoring and membrane filtration-based bioburden testing.
Perform microbiological testing following laboratory methodology, such as Testing Standard, General Method, Specific Method, Pharmacopeia Compendia, and SOPs.
Report any non-conformances. Initiate and/or lead resolution efforts and laboratory investigations.
Maintain a clean and safe working environment; adhere to existing safety protocols and participate in department safety programs.
Report results accurately and maintain good recordkeeping.
Responsible for routine laboratory upkeep and organization.
Maintain laboratory supplies, media and reagents inventory for QC laboratory.
The ideal candidate is self-driven, and task oriented and can work on their own time but will have to meet deadlines.
Comply with all applicable company, site policies and procedures and all regulatory and FDA guidelines.
Assist in reviews, modifies SOPs and other lab documents as necessary.
Manages preventative maintenance and calibration activities on QC instrumentation.
Experience
Requirements and Qualifications:
BS or BA degree in Microbiology or Biology with 5-7 years of relevant microbiology lab experience in a cGMP/FDA regulated industry.
Strong interpersonal skills, including the ability to effectively and efficiently communicate in oral and written forms at any level within the organization and interact effectively with customers and external business professional.
Ability to work independently or as a team member.
Demonstrated hands-on knowledge in Microbiology and USP 71 sterility testing required.
Ability to problem-solve and troubleshoot as necessary.
Ability to identify and implement process improvements, implement creative or novel solutions under minimal supervision.
Commitment and drive to improve manufacturing operations.
Travel Requirements
10% of travel between Imprimis facilities may be required for this position.
Position Type and Expected Hours of Work
This is a full-time position working Monday through Friday in Ledgewood, NJ. Occasional overtime and evening hours and/or weekends may be required as per business needs.
Work Environment & Physical Demands
While performing the responsibilities of the job, the work environment characteristics are representative of the environment the job holder will encounter, and the physical demands are representative of the physical requirements necessary for an employee to successfully perform the essential functions of the job.


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