On Demand Pharmaceuticals (ODP) (www.ondemandpharma.com) is changing the way we make and distribute medicines-by providing them to anyone, anywhere, anytime. We are creating innovative systems to enable our vision to produce critical medicines at the point of care and to secure the pharmaceutical supply chain. As a young organization, ODP offers an exciting opportunity for passionate professionals to make a difference in the world while developing career paths for advancement. ODP is seeking a GMP Sterile Operator / Pharmacy Technician to support our team.
Role Summary:
Under the direct supervision of the Licensed Pharmacist and according to law and standard procedures, manufactures and/or compounds finished drug product, including associated tasks such as cleaning, packaging, sterilization, etc. and performs other technical duties as assigned. Demonstrates leadership in the training of new employees through the trainee's thorough and efficient attainment of competencies.
Responsibilities:
- Prepares finished drug products (503a compounding, 503b compounding, and/or cGMP manufacturing)
- Completes sterilization and release testing of finished compounded products
- Prepares finished drug products for delivery to hospital partner and/or shipping to other customers
- Inspects and unpacks deliveries of products and places them into inventory or storage
- Assists with the development and implementation of state-of-the art processes and workflows
- Assists with training of new employees
- Audits and maintains drug/supply inventory
- Execute R&D, technical transfers and production records/documentation
- Support production operations, including participation in equipment and facility commissioning/qualification/validation activities
- Able to author, review and revise Standard Operating Procedures
- Facilitate deviation investigations, CAPAs, and change controls.
- Ensures compliance with USP 795/797/800, cGMP, Mississippi Board of Pharmacy, and other appropriate regulatory body rules and regulations
- Perform other tasks as required to support production and development schedules
- Adhere to standard operating procedures, company policies and site safety requirements
Standing and Lifting Requirements:
- The position involves extended periods of standing, walking, and moving around the work area.
- Employees in this role are expected to be able to stand and walk for up to 9 hours per day.
- The ability to lift and carry objects weighing up to 35 pounds is required. This may include materials, equipment, and supplies.
- Regular bending, stooping, and reaching to access items at various heights is necessary.
- The employee should be able to perform tasks that involve pushing, pulling, and maneuvering heavy items.
- Candidates must possess the physical strength and stamina to lift, carry, and manipulate objects repeatedly throughout the workday.
- Safe lifting techniques should be employed to prevent strain or injury.
Minimum Qualifications:
- High school graduate or equivalent or associate's degree
- 2 years of related experience
- Pharmacy technician registration with the Mississippi Board of Pharmacy
- National Pharmacy Technician Certification, current and in good standing
- Strong computer skills
- Ability to meet physical and environmental requirements for drug production
- Ability to meet gowning qualification requiremen[BC1]ts
Preferred Qualifications:
- Graduate of certified training program/healthcare career college
- Experience in non-sterile and/or sterile compounding operations in a hospital or health system
- Board certification in sterile compounding or equivalent certification/training
- AS/BS engineering or equivalent Life Sciences discipline preferred
- Prior experience operating within GMP environment
On Demand Pharmaceuticals is an equal opportunity employer.On Demand Pharmaceuticals does not discriminate in employmentwith regard torace, color, religion, national origin, citizenship status, ancestry, age, sex(including pregnancy, gender identity, or related medical conditions), sexual orientation, marital status, physical or mental disability, past or presentmilitary serviceor any other characteristic protected by law.