Empower Pharmacy
Pharmaceutical Operations Specialist, 503A
Empower Pharmacy, Houston, Texas, United States, 77246
Pharmaceutical Operations Specialist, 503A
Pay Competitive Location Houston/Texas Employment type Full-Time Job Description
Req#: 1952
Company Overview
Empower Pharmacy and Empower Pharma are the country's most advanced compounding pharmacy and FDA-registered outsourcing facility, providing pharmacies, healthcare practitioners and patients with personalized pharmaceuticals in the integrative health and wellness market. We currently serve more than 3.5 million patients across the United States. With facilities that tout the latest automated pharmaceutical manufacturing equipment, cleanrooms, environmental controls and professional staff, we are proud of our leadership in the compounding industry. How we work is just as important as the work we do. We know that the basis of a great company is our people. Our diverse culture is the foundation for our growing company’s broader perspective: to serve the needs of our patients through innovation. We are always seeking new ways to advance the manufacture and distribution of quality-of-life products through cutting-edge processes and technology. Our vision to be the leader in compounding never wavers. With modern, streamlined systems, state-of-the-art facilities and a dedicated team, we strive to deliver access to quality, affordable medication for patients across the country.
Position Summary
The 503A Pharmaceutical Operations Specialist reports to the Manufacturing Specialist Manager and is responsible for executing projects and tasks related to continuous improvement using lean manufacturing principles as well as strategic implementation of upscaling/future projects.
Duties and Responsibilities
Understands current processes and identify opportunities for improvement, including conducting interviews, observing technicians, collecting data, trending data and analyzing data for improvement Performs regular audits of production processes and helps implement lean six sigma manufacturing principles (5S, OSW/SWIs, Gemba, etc.) Develops and maintains Standard Operating Procedures (SOPs), Standard Work Instructions (SWIs) and Forms used in both sterile and non-sterile compounding operations Works in close collaboration with training and production to develop a robust training program on new processes Collaborates with Quality to maintain alignment of manufacturing systems processes with all quality system requirements to improve overall quality of the product Identifies areas of waste and improves efficiencies and develop strategies to reduce or eliminate it Improves visibility of KPI’s reporting, and development improvement actions based on KPI analysis Collaborates with R&D for downstream processing development activities and optimization of manufacturing processes including formulation. Assist if required in the development/optimization of upstream manufacturing processes Serves as the SME for details of each specific operation they are supporting Provides support to facilitate closure and completion of investigations, deviations and CAPAs (Corrective and Preventative Actions) Works closely with quality and engineering teams to help implement new devices, equipment, and processes into production Works with the production team to identify areas for process improvement and implement changes to increase efficiency, reduce waste, and improve product quality Complies with required PPE while utilizing aseptic technique and minimizing contamination Works with cross functional departments to assist in the closure of NCI’s (non-conformance incidents) Adapts to and assumes unforeseen responsibilities as the company requires Performs other duties as assigned To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions. While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision. Employee must be able to stand and walk for extended periods of time for consecutive days. Employee must be able to lift up to 30 lbs.
Knowledge and Skills
Strong understanding of US Pharmacopeia ( US P ) 795, 797, and 800 guidelines and 503A regulations Understanding of standard concepts, practices, and procedures within the pharmaceutical field and aseptic practices Ability to operate manufacturing equipment and perform various manufacturing processes such as a vial washer, depyrogenation tunnel and semi-automated filling line Excellent attention to detail and ability to maintain accurate records Strong problem-solving and communication skills Ability to work independently as well as part of a team Willingness to work flexible hours as needed Communicate effectively both verbally and written with personnel at all levels in a professional manner Excellent computer skills in MS Office (Excel, Word, PowerPoint) Must be able to gown into cleanroom (daily if needed) and pass media fill tests bi-annually
Experience and Qualifications
Bachelor's degree in STEM (science, technology, engineering, or math) , life sciences related field , or equivalent experience in pharmaceutical manufacturing 3+ years of experience in a pharmaceutical environment 1+ years of experience in a 503A compounding pharmacy environment required Experience with aseptic techniques and cleanroom operations Strong cGMP (current Good Manufacturing Practices) , aseptic processing, and USP 797/800 background. USP 795, 797, 800 and/or cGMP compliance Familiarity with ERP systems CERTIFICATES, LICENSES, REGISTRATIONS* Pharmacy technician trainee or certification required IV Certification highly preferred
Benefits
Health/Vision/Dental Insurance 401k with company matching Paid Time Off (PTO) Volunteer Time Off (VTO) Paid Holidays
Bachelor's degree in STEM (science, technology, engineering, or math) , life sciences related field , or equivalent experience in pharmaceutical manufacturing 3+ years of experience in a pharmaceutical environment 1+ years of experience in a 503A compounding pharmacy environment required Experience with aseptic techniques and cleanroom operations Strong cGMP (current Good Manufacturing Practices) , aseptic processing, and USP 797/800 background. USP 795, 797, 800 and/or cGMP compliance Familiarity with ERP systems CERTIFICATES, LICENSES, REGISTRATIONS* Pharmacy technician trainee or certification required IV Certification highly preferred
Strong understanding of US Pharmacopeia ( US P ) 795, 797, and 800 guidelines and 503A regulations Understanding of standard concepts, practices, and procedures within the pharmaceutical field and aseptic practices Ability to operate manufacturing equipment and perform various manufacturing processes such as a vial washer, depyrogenation tunnel and semi-automated filling line Excellent attention to detail and ability to maintain accurate records Strong problem-solving and communication skills Ability to work independently as well as part of a team Willingness to work flexible hours as needed Communicate effectively both verbally and written with personnel at all levels in a professional manner Excellent computer skills in MS Office (Excel, Word, PowerPoint) Must be able to gown into cleanroom (daily if needed) and pass media fill tests bi-annually About the company
Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000. Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility. An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report . NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.
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Pay Competitive Location Houston/Texas Employment type Full-Time Job Description
Req#: 1952
Company Overview
Empower Pharmacy and Empower Pharma are the country's most advanced compounding pharmacy and FDA-registered outsourcing facility, providing pharmacies, healthcare practitioners and patients with personalized pharmaceuticals in the integrative health and wellness market. We currently serve more than 3.5 million patients across the United States. With facilities that tout the latest automated pharmaceutical manufacturing equipment, cleanrooms, environmental controls and professional staff, we are proud of our leadership in the compounding industry. How we work is just as important as the work we do. We know that the basis of a great company is our people. Our diverse culture is the foundation for our growing company’s broader perspective: to serve the needs of our patients through innovation. We are always seeking new ways to advance the manufacture and distribution of quality-of-life products through cutting-edge processes and technology. Our vision to be the leader in compounding never wavers. With modern, streamlined systems, state-of-the-art facilities and a dedicated team, we strive to deliver access to quality, affordable medication for patients across the country.
Position Summary
The 503A Pharmaceutical Operations Specialist reports to the Manufacturing Specialist Manager and is responsible for executing projects and tasks related to continuous improvement using lean manufacturing principles as well as strategic implementation of upscaling/future projects.
Duties and Responsibilities
Understands current processes and identify opportunities for improvement, including conducting interviews, observing technicians, collecting data, trending data and analyzing data for improvement Performs regular audits of production processes and helps implement lean six sigma manufacturing principles (5S, OSW/SWIs, Gemba, etc.) Develops and maintains Standard Operating Procedures (SOPs), Standard Work Instructions (SWIs) and Forms used in both sterile and non-sterile compounding operations Works in close collaboration with training and production to develop a robust training program on new processes Collaborates with Quality to maintain alignment of manufacturing systems processes with all quality system requirements to improve overall quality of the product Identifies areas of waste and improves efficiencies and develop strategies to reduce or eliminate it Improves visibility of KPI’s reporting, and development improvement actions based on KPI analysis Collaborates with R&D for downstream processing development activities and optimization of manufacturing processes including formulation. Assist if required in the development/optimization of upstream manufacturing processes Serves as the SME for details of each specific operation they are supporting Provides support to facilitate closure and completion of investigations, deviations and CAPAs (Corrective and Preventative Actions) Works closely with quality and engineering teams to help implement new devices, equipment, and processes into production Works with the production team to identify areas for process improvement and implement changes to increase efficiency, reduce waste, and improve product quality Complies with required PPE while utilizing aseptic technique and minimizing contamination Works with cross functional departments to assist in the closure of NCI’s (non-conformance incidents) Adapts to and assumes unforeseen responsibilities as the company requires Performs other duties as assigned To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions. While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision. Employee must be able to stand and walk for extended periods of time for consecutive days. Employee must be able to lift up to 30 lbs.
Knowledge and Skills
Strong understanding of US Pharmacopeia ( US P ) 795, 797, and 800 guidelines and 503A regulations Understanding of standard concepts, practices, and procedures within the pharmaceutical field and aseptic practices Ability to operate manufacturing equipment and perform various manufacturing processes such as a vial washer, depyrogenation tunnel and semi-automated filling line Excellent attention to detail and ability to maintain accurate records Strong problem-solving and communication skills Ability to work independently as well as part of a team Willingness to work flexible hours as needed Communicate effectively both verbally and written with personnel at all levels in a professional manner Excellent computer skills in MS Office (Excel, Word, PowerPoint) Must be able to gown into cleanroom (daily if needed) and pass media fill tests bi-annually
Experience and Qualifications
Bachelor's degree in STEM (science, technology, engineering, or math) , life sciences related field , or equivalent experience in pharmaceutical manufacturing 3+ years of experience in a pharmaceutical environment 1+ years of experience in a 503A compounding pharmacy environment required Experience with aseptic techniques and cleanroom operations Strong cGMP (current Good Manufacturing Practices) , aseptic processing, and USP 797/800 background. USP 795, 797, 800 and/or cGMP compliance Familiarity with ERP systems CERTIFICATES, LICENSES, REGISTRATIONS* Pharmacy technician trainee or certification required IV Certification highly preferred
Benefits
Health/Vision/Dental Insurance 401k with company matching Paid Time Off (PTO) Volunteer Time Off (VTO) Paid Holidays
Bachelor's degree in STEM (science, technology, engineering, or math) , life sciences related field , or equivalent experience in pharmaceutical manufacturing 3+ years of experience in a pharmaceutical environment 1+ years of experience in a 503A compounding pharmacy environment required Experience with aseptic techniques and cleanroom operations Strong cGMP (current Good Manufacturing Practices) , aseptic processing, and USP 797/800 background. USP 795, 797, 800 and/or cGMP compliance Familiarity with ERP systems CERTIFICATES, LICENSES, REGISTRATIONS* Pharmacy technician trainee or certification required IV Certification highly preferred
Strong understanding of US Pharmacopeia ( US P ) 795, 797, and 800 guidelines and 503A regulations Understanding of standard concepts, practices, and procedures within the pharmaceutical field and aseptic practices Ability to operate manufacturing equipment and perform various manufacturing processes such as a vial washer, depyrogenation tunnel and semi-automated filling line Excellent attention to detail and ability to maintain accurate records Strong problem-solving and communication skills Ability to work independently as well as part of a team Willingness to work flexible hours as needed Communicate effectively both verbally and written with personnel at all levels in a professional manner Excellent computer skills in MS Office (Excel, Word, PowerPoint) Must be able to gown into cleanroom (daily if needed) and pass media fill tests bi-annually About the company
Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000. Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility. An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report . NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.
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