Jubilant DraxImage, Inc.,a nationwide radiopharmaceutical company, is dedicated to nuclear medicine. We use our 25 years of experience in Nuclear Pharmacy to provide our customers with the best service and safest products. The Jubliant Radiopharmacies Network of facilities positions us to serve national GPO’s, regional systems, as well as standalone clinics and hospitals. Through our open formulary, we provide choice by giving our customers access to all radiopharmaceuticals available, allowing them to better serve their patients. Jubliant Radiopharmacies provides the strength of national coverage while remaining connected to our local community. We are patient focused and community driven to ensure that we are intimate with our healthcare partners’ needs.

If you would like to work with a large company with an independent pharmacy mindset and decision making process, Jubliant Radiopharmacies is the pharmacy for you.

We are currently seeking aQuality/Regulatory Compliance Specialist to support our pharmacy operation.

RESPONSIBILITIES:

• Coordinate training and implementation of cGMP SOP’s to the PET and other JUBILANT facilities which are involved in the manufacture or production of radiopharmaceuticals;
• Obtain and maintain knowledge of policies and procedures that are applicable to the JUBILANT pharmacies;
• Perform pharmacy radiation and safety audits to ensure compliance with JUBILANT, local, state and federal regulations and with a focus on accountability on improving program success;

• Provide written summary of recommendations to Director of Quality & Safety and JUBILANT management team; facilitate local implementation of JUBILANT Radiation Safety and EHS programs / initiatives while performing on-site audits; evaluate effectiveness of the corrective action program following safety audits and implement improvements; report findings through appropriate JUBILANT management structure;
• Support the JUBILANT Quality and Safety Department as required, including helping with any decommissions, RSO training, and general quality and safety pharmacy support as needs dictate;
• Assist in the development of standardized policies and procedures to facilitate cGMP implementation;
• Participate in regulatory compliance audits of manufacturing operations and processes of the JUBILANT locations, as directed;
• Participates in the selection, quality screening and auditing of vendors/suppliers used in the PET drug manufacturing process;
• Assist in gathering and interpretation of data used to quantify the metrics related to the PET Quality System;
• Assist with the qualification of equipment and processes; review verification and validation data associated with PET drug manufacturing;
• Provide the development and training that is associated with the PET materials/components used in the PET Specification Book;
• Assist in escorting and attending FDA inspections to the PET sites, provide the necessary support to the QM’s;
• Support the PET QA systems by auditing documentation, systems and adherence to cGMP across all PET sites;

• Assist in the maintenance and support of the PET QA systems including CAPA, Change control, Deviation requests, Batch Trend Tracking, and SOPs;

• Provide a written report of audit results for the participating sites quality manager and senior management team, including all required modifications;
• Provide guidance to JUBILANT quality managers to ensure compliance through follow-up actions as necessary to regulatory audits;
• Perform on-site and remote training to assist the local operation in achieving compliance with cGMP and other regulatory requirements as needed;
• Assist in the development of training materials for use by quality managers, PET operations staff, and other production staff to address regulatory compliance, cGMP practices or other regulatory issues as required;
• Perform or assist with any operations, as required to maintain workflow and to meet schedules and quality requirements; Notify supervision of unusual equipment or operating problems and the need for additional material and supplies;
• Participate in corporate compliance meetings where directed; participate in any variety of meetings and work groups to integrate activities, communicate issues, obtain approvals, resolve problems and maintain specified level of knowledge pertaining to new developments, requirements, policies, and regulatory guidelines;
• Develop and maintain working operator level knowledge of cyclotron functions;
• Perform other duties as required.

EXPERIENCE:

• Bachelor of Science degree from an accredited college.

• Minimum 4-5 years experience in a Quality Manufacturing System Environment;
• Previous responsibilities and experience working with regulatory agencies required;
• Bachelor degree in related field required;

• Superior computer skills and proficiency in the Microsoft Office Suite, with the ability to master new software programs Ability to establish priorities, multi-task in a fast-paced environment, work independently, and meet deadlines while providing accurate and complete work;
• Highly developed organizational and follow-through skills;
• Strong verbal communication skills, interpersonal and customer service skills, and a demonstrated ability to work effectively with team members throughout an organization;
• High integrity and professionalism; ability to maintain confidentiality with sensitive materials;

• Must be able to successfully pass company’s background check and pre-employment drug test;
• Ability to operate a vehicle and maintain a valid driver’s license, also required;
• Demonstrated leadership skills in motivating team members and meeting performance goals in a pharmacy environment;
• Demonstrated strength in customer relationship management / recovery;
• Experience in budget development, management and profit and loss analysis;
• Ability to analyze and resolve complex issues, both technical and interpersonal;
• Highly organized and very effective time management skills;
• Strong written and verbal communication skills;
• Ability to negotiate and defuse conflict;
• Self-motivator, independent, cooperative, flexible, creative;
• Customer focused; team oriented;

Qualified candidates please begin the application process by clicking the “apply” button at the top or bottom of this page or go to jdiri.com/about/join. Jubliant Radiopharmacies offers a competitive salary and benefits package, non-nuclear pharmacist training, relocation assistance and the opportunity to work for the fastest growing radiopharmaceutical company in the nation.

If qualified individuals with a disability need assistance in applying for this position, call Human Resources at 407-455-6700 informing us regarding the nature of your request and providing your contact information.

AA/DFWP/EOE –M/F/Individuals with Disabilities/Protected Veteran

Job Type: Full-time

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