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Empower Pharmacy · 1 day ago

Quality Training Specialist - Pharm Tech Required

Houston, TX

Full-time

Onsite

Mid Level

3+ years exp

Empower Pharmacy is a company dedicated to delivering safe, affordable, innovative medication. The Quality Training Specialist is responsible for developing and maintaining training programs that ensure compliance with cGMP standards and FDA regulations, while also facilitating onboarding and ongoing education for staff.

Health CarePharmaceutical

Responsibilities

Develops, maintains, and delivers job-specific training programs for sterile and non-sterile manufacturing personnel, compounding technicians, and support staff across 503A and 503B pharmacies

Supports the implementation and ongoing maintenance of a robust, compliant training program, including curriculum design, training matrices, qualification protocols, and Learning Management System updates

Facilitates onboarding and continued education for staff by coordinating hands-on training, classroom instruction, competency assessments, aseptic technique qualifications, and gowning certifications as applicable

Collaborates with Quality Assurance, manufacturing, and SMEs to ensure training materials reflect the most current Standard Operating Procedures, regulatory requirements (e.g., United States Pharmacopeia (USP) 795, 797, 800, FDA, Drug Enforcement Agency), and process updates

Assists in internal audits, regulatory inspections, and quality investigations by maintaining accurate training records and identifying training gaps or compliance risks through routine training effectiveness reviews

Qualification

CGMP knowledgeFDA guidelinesTraining program developmentTrain-the-Trainer certificationAseptic technique trainingInterpersonal skillsCommunication skillsPresentation skillsCollaborationProblem-solving

Required

Minimum of 3 years of experience in a training, quality assurance, or manufacturing role within a pharmaceutical, compounding, or other cGMP-regulated environment

Working knowledge of cGMP, USP 795, 797, 800, and FDA guidelines related to training, manufacturing, and aseptic practices in sterile and non-sterile environments

Excellent interpersonal, communication, and presentation skills with the ability to train and influence employees at all levels and translate technical content into clear, engaging instruction

Preferred

Bachelor's degree in life sciences, pharmaceutical sciences, education, or a related field preferred; equivalent combination of education and experience may be considered

Train-the-Trainer certification, Aseptic Gowning/Technique Trainer qualification, or equivalent instructional certification preferred