Shire Jobs

Onsite - Alachua, FL USA Mission The successful candidate will be responsible for establishing and managing the Sample Management, Stability and Reference Standard programs at Beacon Therapeutics. This will include, but is not limited to, generation of the governing SOPs, forms and electronic tools to track and trend operational activities related to the above programs. As part of this role, the incumbent will have an opportunity to interact with internal and external stakeholders. Reporting Relationship • The Sample Management and Stability coordinator will report directly to the Director or Head of Quality Control or designee Duties and Responsibilities • Serve as the primary person responsible for overseeing the Sample Management, Stability and Reference Standard programs. • Author, review and/or approve SOPs and associated documents to support and ensure traceability/chain of custody for the above programs. • Author, review and/or approve protocols and reports related to Sample Management, Stability and Reference Standard programs. • Work with colleagues from the Manufacturing, Analytical Development and Quality Assurance functions to develop process(es) for receiving and distributing in-process, release and stability samples for internal and external testing. • Establish centralized system for tracking end-to-end sample flow from receipt to generation of certificate of analysis (CoA). • Establish processes and tools to manage inventory and chain of custody for stability and reference standard samples. • Assist with initiating change controls, deviations, CAPA and/or performing investigations, as applicable for the above programs. • Establish tools to track and trend batch analysis and stability data. • Assist the team with departmental activities, including but not limited to reconciling QC records, generating and placing purchase orders, routine housekeeping, etc. • Participate in internal and external audits to support sample management, stability and reference standard programs. • It should be noted that this job description is subject to change at any time. Educational Qualifications • Bachelor’s degree Additional Qualifications • Minimum five plus (5+) years of experience working in a GxP environment. • Proficient with Microsoft Office Suite, Project Management programs (e.g., Smartsheet), etc. • Experience working with contract testing laboratories, highly preferred. • Participating in internal and external audits, preferred but not required. • Proficient in oral and written communication. Physical Requirements • Physical demands: (check one) ☐ sedentary (< 10 lbs.) ☒ light work (< 20 lbs.) ☐ medium work (< 50 lbs.) ☐ heavy work (< 100 lbs.) ☐ very heavy work (>100lbs.) • Physical activity: (check all that apply) ☒repetitive motion ☒ balancing ☒stooping ☒lifting ☐climbing ☒kneeling/crouching ☐crawling ☒reaching ☒standing ☒ typing/grasping ☒walking ☐pushing/pulling ☒hearing • Visual acuity (preparing/analyzing data, transcribing, reading, use of measuring devices, machinery labels, color differentiation, etc.) • Working conditions (indoor/outdoor, noise levels, hazards, working quarters) Supervisor Responsibilities • This position does not require previous supervisory experience.