American Statistical Association - ASA
Irving / Global
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Irving / Global
Job Opportunity At Carie Boyd PharmaceuticalsCarie Boyd Pharmaceuticals is a national 503B FDA outsourcing registered facility, enabling us to meet the needs of our patients and prescribers through a variety of office use products including but not limited to injectables, pellets, and topicals. Being a member of the Carie Boyd team means prioritizing patient needs, dedication to quality, and the drive to continue to scale our innovative business in new and diverse ways.Responsibilities:Perform routine tasks including: Sampling: personnel monitoring (PM) and environmental monitoring (EM)Incubate and read sample plates (TSA and SDA) per standard operating proceduresSend off PM & EM samples to contract laboratory for identificationConfirm growth promotion test resultsDocumenting actionsStart-Up and In-Process ChecksLabel VerificationAssist production to verify steps critical to quality of final productPerform visual inspectionsEnforce good hygiene practices and aseptic techniques in GMP areasSuccessfully pass garbing qualification to enter clean roomsPerform aseptic processing media fill simulations for personnel certifications and garb qualifications for personnel monitoringClearly communicate and enforce the company's quality expectations outlined in standard operating procedures in a productive mannerPrepare product to be shipped to contract testing laboratories, select appropriate testing on portals, and correspond with laboratories, as neededPerform GDP review of documents, as neededAssist production with reconciliation, as neededAssist Quality Management with other Quality Control duties, as neededHas the decision-making authority for the following: Start-up and shut down of compounding suitesQualifications:Minimum 3 years combined GMP experience in any of the following: contract manufacturing, food packaging or manufacturing, medical device, and / or 503B outsourcing facility. Strong documentation skills Cleanroom experience preferred, but not required Aseptic Processing and Aseptic Technique skills preferred Confidentiality The employee must maintain the confidentiality of company information and, pursuant to State and Federal Law (including the Health Insurance Portability and Accountability (HIPAA) Act of 1996), protected health information.EOE/ADA Carie Boyd Pharmaceuticals is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, Carie Boyd Pharmaceuticals will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer.
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