Geritrex, LLC Quality Assurance Manager in Middletown, New York
The Quality Manager position is responsible for overseeing all activities within the Quality Unit, including supervision of Quality personnel. The primary function is to ensure compliance with all regulatory agency requirements, as well as customer and internal quality system requirements. This includes quality system implementation and maintenance, documentation management, site-wide quality system training, raw material inspection, and product release. This position requires extensive independent judgment and attention to detail.
Responsibilities of the Quality Manager include but are not limited to:
Facilitate and manage training on Current Good Manufacturing Practices.
Overseeing the Quality Assurance Supervisor and QA Floor Personnel.
Overseeing the Quality Assurance Release Supervisor and assisting when needed.
Review and/or approve documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, that are submitted to Quality for approval.
USP Water System, daily checks and working with water contractor.
Investigating and composing deviations.
Maintenance of training program and training records.
Manage calibration, validation, and certification of equipment and facilities.
Provide QA oversight and evaluation of proposed change controls.
Pest Control activities with vendor.
Maintain licensing for NYS Dept. of Health, Office of Controlled Substances and US FDA.
Maintain inventory control of Controlled and Scheduled Drug and conduct reporting on Form #, Date and Frequency.
Gather and file semi-annual EPA 2018 Wastewater Sampling Results.
Experience in quality oversight of manufacturing operations, batch record review, and batch release. Experience with documentation of quality management system (deviations, CAPAs, change controls, training, etc.) Experience leading, managing, and executing a variety of technical projects and programs, especially with an emphasis on FDA compliance, Manufacturing, and Controls (CMC). Experience supporting scale-up, technology transfer, and cGMP process start-ups, including Pre-Approval Inspections (PAIs). Strong familiarity with CGMP facility/utility/equipment design, construction, commissioning, and/or validation. Experience working at large, established multi-nationals in addition to small, growing organizations. At least 5 years of total experience in the biotechnology industry working in two or more of the following departments:
Engineering / Automation
Technical Services / Manufacturing Sciences
Desired Aptitude and Skill Set:
Superior oral communication, including good phone presence
Detail and accuracy second-to-none
Root cause analysis experience and/or CAPA training
Know when to ask for help and who to ask
Fast learner and accepting of change
Formal writing style
Expert distiller and communicator, including documentation formatting
Ability to perform under stress
Excellent problem solving skills
Ability to organize time for multiple tasks in a dynamic environment.
Seasoned soft skills
When needed, ?take the lead? and facilitate decision making
Excellent understanding of FDA?s cGMPs (i.e., cGxP Quality Systems)
Must be authorized to work in the US and able to demonstrate English language proficiency.
Desired Educational Background:
Bachelor of Science in life science or engineering discipline from a four-year program at an accredited institution.
Continuing education or certificates in FDA/EMA regulatory compliance and CGxP/ICH/ISO quality is a plus.
Geritrex, LLC specializes in the pharmaceutical research, development and manufacturing of various skincare, personal care and over-the-counter (OTC) pharmaceutical products. The company also works to provide cost effective alternatives to many of today's brand name products. All of Geritrex's products comply with the FDA's (US Food and Drug Administration) Good Manufacturing Practice regulations which require strict quality assurance testing in order to ensure that all products are safe and effective.