["Supply Chain Specialist 2, Compliance","Supply Chain Specialist 2, Compliance"]

Position OverviewThe Supply Chain Compliance Specialist 2 is responsible for actions, processes, and audit readiness at FDBN. This role supports all Supply Chain operations, procedures, systems, processes, and GXP related matters in accordance with the GXP requirements defined in the Pharmaceutical Quality System. Support includes initiation and investigation of internal and external exceptions impacting Supply Chain, supporting the establishment and implementation of comprehensive corrective and preventative actions to prevent recurrence and drive improvements, and coordinating vendor change notifications, raw material enrollment, and supplier complaints. The role coordinates internal and external changes impacting Supply Chain planning, master data, warehouse and logistics, and customer requirements.Job DescriptionResponsibilities include supporting optimization projects, analyzing and revising master data issues, leading change management records, performing investigations and CAPAs, collaborating with cross‑functional teams, and ensuring data integrity and audit readiness.What You'll DoCreates, revises, and maintains current Standard Operating Procedures (SOPs), work instructions, training compliance standards, and applicable documentation to support the Supply Chain organization.Supports optimization projects to ensure continuous process improvements and development for the organization and/or client.Supports the analysis, revision, and resolution of master data issues, including inventory, SAP processes, cycle counting and other processes within the Supply Chain function.Coordinates and leads change management records for raw material enrollment, vendor change notifications, and supplier complaints.Performs, initiates, and supports change management records, investigations, CAPAs, 3C, and CI activities for Drug Substance and Drug Product.Works in multiple functions and participates in projects/initiatives for Supply Chain support; including SAP, Warehouse, Shipping/Logistics, Master Data, Weigh and Dispense, and Raw Material Sampling.Leads investigations, updates SOPs, implements CAPAs, performs investigations, as needed.Collaborates with cross‑functional teams and subject matter experts (SMEs) for assessment and necessary actions to meet schedules, compliance actions, or project initiatives.Plans, facilitates, and coordinates with SMEs, Quality, Manufacturing, Process Science, and Customers to ensure changes are implemented compliantly within defined timelines and documented in the appropriate quality system.Ensures data integrity and compliance for operations and audit readiness.Performs other duties as assigned.Knowledge & SkillsEffective communication, both written and oral.Results‑oriented and strong interpersonal skills.Effective problem‑solving skills.Ability to effectively present information to others.Ability to work cross‑functionally with a diverse team.Ability to prioritize with multiple priorities.Basic RequirementsHigh School or GED and 6 years of relevant work experience.OR, BS/BA degree in Supply Chain, Engineering, Information Science, Data Management, or Life Science related field and 2+ years relevant work experience.Preferred RequirementsBA plus 3+ years of relevant work experience.Experience with SAP S4/HANA or other SAP ERP system.GMP regulation experience.Audits with FDA or similar organization management.Advanced Excel skills.BenefitsOur programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision, and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry‑leading 401(k) savings plan, insurance coverage, employee assistance programs, and various wellness incentives. We support life‑work balance with paid vacation time, sick time, and company holidays.Physical RequirementsMust be able to work in an environment that may necessitate respiratory protection; may work in mechanical/production spaces requiring hearing protection and enrollment in a hearing conservation program; may operate a motor vehicle or powered industrial truck; discern audible cues; perform tasks with 20/20 corrected vision, including distinguishing color; ascend or descend ladders, scaffolding, ramps; stand or sit for prolonged periods (up to 60 minutes); use repetitive motions with wrists, hands, and fingers; operate machinery and/or power tools; lift objects up to 33 lbs; bend, push or pull, reach materials 18"–60"; work in warm/cold environments; outdoors in precipitation and wind; inside small or enclosed spaces; at heights greater than 4 feet.#J-18808-Ljbffr