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Harrow (NASDAQ: HROW) is an eye health pharmaceutical company focused on the development, sale, and distribution of innovative ophthalmic prescription medications. The Harrow platform is designed to provide both patients and physicians with access to affordable medicines.
Our mission as a growing leader in the ophthalmic healthcare market is driven by two core values: (1) unyielding dedication to innovation and (2) a mission of providing affordable and accessible medications. We pride ourselves on closely listening to the needs of providers and their patients, so we can do everything in our power to address them with high-quality products and services.
Our worthwhile mission is producing amazing financial results, and because we've produced a 72% compound annual growth rate for our first eight years in business, we are one of the fastest-growing ophthalmic pharmaceutical companies in the United States.
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, strong organizational skills, computer proficiency, and a basic understanding of microbiology and laboratory instrumentation. In addition, practical 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 various duties related to the efficient and effective functioning of a Quality Control lab. Assists in reviewing and modifying SOPs and other lab documents as necessary.
* 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 methodologies, such as Testing Standards, General Method, Specific Method, Pharmacopeia Compendia, and SOPs.
* Report any non-conformances. Initiate and 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 the QC laboratory.
* The ideal candidate is self-driven and task-oriented and can work independently but must meet deadlines.
* Comply with all applicable company and site policies and procedures and all regulatory and FDA guidelines.
* Assist in reviewing and modifying SOPs and other lab documents as necessary.
* Manages preventative maintenance and calibration activities on QC instrumentation.
Requirements and Qualifications
* BS or BA degree in Microbiology or Biology
* 5-7 years relevant microbiology lab experience in a cGMP/FDA-regulated industry.
* Strong interpersonal skills, including the ability to communicate in oral and written forms effectively and efficiently at any level within the organization and interact effectively with customers and external business professionals.
* 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.
Work Environment/Physical Demands
* The employee may frequently be required to sit and talk or hear.
* The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, and crouch.
* The employee must occasionally lift and/or move up to 25 pounds.
* A cleanroom environment requires that gowning in the form of hospital scrubs, bunny suits, gloves, and steel-toe boots be worn. Also, no makeup or jewelry can be worn when working in a clean room environment.
* Specific vision abilities in this job include close vision, depth perception, and the ability to adjust focus.