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The Controlled Substance Specialist is a dual focused role responsible for:
Supporting the site regulatory compliance profile related to the receipt, testing, manufacture, distribution, and reporting of controlled substances for the two Fagron Sterile Services Wichita Facilities.
Supporting the New Product Develop team by helping coordinate and support the launch of new products from the site.
- Assist with maintaining the Controlled Substance (CS) program.
- Assist with site gap assessments and development of action plans to ensure regulatory compliance with DEA, FDA (cGMP) and State Pharmacy Boards.
- Manage/monito all CS vault processing and inventory levels to ensure compliance to DEA requirements and site procedures.
- Responsible for working though all CS inventory discrepancies to final resolution.
- Responsible for assisting with all CS inventory accountability and reconciliation activities.
- Support all DEA inspections, correspondence, and help ensure site readiness.
- Assist with submitting all appropriate CS documents to the DEA.
- Track colleague training related to CS in order to ensure training requirements are current and are completed on time.
- Maintain all records and documentation as required for CS.
- Assist with development and growth of a Security culture among all colleagues and contractors to help ensure CS compliance
- Collaborate cross-functionally to gain alignment on compliance and quality issues.
- Assist with the coordinating and reporting of all CS destruction activities.
- Responsible for assisting with CS customer complaints including all samples returned to Fagron.
- Support of, and compliance with, all quality requirements.
- Work to continuously improve our compliance profile in regards to the handling of CS.
- Support continuous improvement of site operations including developing and/or reporting of metrics related to CS.
- Support documentation life-cycle (SOPs, training material, batch records, etc.) as needed to maintain compliance and continuous improvement.
- Support continued manufacturing, product life-cycle and the introduction of new products at the site.
- Executing new product development plans in consultation with the production staff, production planners, project managers and product development staff including:
- Coordinating and tracking pre-development requirements
- Communication and coordination with supply chain regarding availability of material
- Coordination of manufacturing activities related to new product development
- Communicates project status and issues horizontally and vertically in a transparent and timely manner including:
- Start of activity triggers for cross-disciplinary action items (i.e. marketing, sales, etc.)
- Status stability results across products
- Status of document reviews and approvals
- Develop and manage our product National Drug Code (NDC) numbering program and bi-annual reporting of products sold.
- Initiate label generation documentation, coordinate new label design review and change control management as well as all label modifications.
- Execute first lot to stock checklists for all New Product Development launches.
- Manage other projects as deemed necessary by management
Ξεχωρίστε από το πλήθος
- A Bachelor Degree is preferred.
- 5 to 7 years relevant experience to include Project Management, operations, regulatory compliance and/or pharmaceutical development experience preferred
- A minimum of 3+ Years of leading cross-functional team in a matrixed organization.
- Strong project management, budget, and presentation skills required.
- Familiarity with the Drug Development Process as appropriate
- Familiarity with Lean Six Sigma Principles/Operational Excellence
- Experience working with popular ERP systems (i.e. SAP, JDE, MAPICS, etc.) is required
- Chair internal and cross-disciplinary team meetings, provide agendas, and issue minutes with follow-up actions identified
- Experience interpreting compliance requirements and regulations is required.
- Knowledge of DEA and state regulations pertaining to shipping controlled substances preferred.
- General knowledge of the pharmaceutical industry, innovator and/or generics is preferred (experience/knowledge related to parenteral or biologic manufacturing is strongly preferred).
- Experience working in a cGMP environment is strongly preferred.
- Ability to synthesize detailed information and provide critical insights across functional areas.
- Experience managing small to medium sized continuous improvement projects is preferred.
- General knowledge of DEA requirements as they relate to distribution and SOM is preferred.
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.