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Quality Assurance/Regulatory Affairs Specialist

Company: Hilco Vision
Location: Fairfield
Posted on: November 21, 2022

Job Description:

Hilco Vision is an industry leading global eyewear/eye care company delivering comprehensive solutions to customers, built on a platform of innovation and operational excellence. Our goal is to take pain points away from our customers' lives, increasing simplicity and making our customers successful. Hilco has direct subsidiaries in the USA, UK, Germany, Australia, China, and the Netherlands, and our product portfolio is concentrated on five primary product categories: Professional Tools, Vision Protection, Consumer Accessories, Lenscare and Eye Care.The QA/RA (Quality Assurance/Regulatory Affairs) Specialist is responsible for managing and overseeing the quality and compliance processes in the Fairfield, OH facility to ensure federal and state compliance. You will assist with regulatory compliance needed to fulfill requirements for NABP Drug Distribution Accreditation and individual state requirements. Train, support and assist team members in processing quality policies and procedures. You will have project management responsibilities related to state licensing, distribution related projects, including supporting distribution operations. Assist with the acquisition and maintenance of all applicable wholesale licenses and/or personal licenses and accreditations/certifications required for Hilco Vision to receive, store, and ship prescription drugs and devices, and over-the-counter products throughout the United States and its territories. You will assist with audits and inquiries from various regulatory agencies, including, Board of Pharmacy, FDA, and other State and Federal Regulators and internal stakeholders.A Little Bit About You: You have a BA/BS degree, or equivalent work experience, with 3 - 5 years of experience working in a Quality, Regulatory and/or Compliance roleYou have a strong commitment to integrity, ethical business conduct, and legal complianceYou have knowledge and understanding of Pharmaceutical Supply Chain in relationship to Federal and State licensing requirements for wholesale distributorsYou have experience with federal and state licensing agencies, such as Boards of Pharmacy, state professional licensing agencies and NABP (DDA Accreditation)You're familiar with researching legislation and regulatory guidanceYou have strong computer skills, including the MS Office suite, and have an aptitude to learn M3, or other ERP systemsYou pay great attention to detail and are able to deal with ambiguity, asking questions for clarity in order to be successfulHighly resourceful, you are a self-starter who can manage multiple projects concurrently and have the ability to work cross-functionally and independentlyYou're adept at managing sensitive and confidential information, and can balance multiple priorities and assignments when neededPreferred Designated Representative experience and/or licensure, experience with DSCSA, Drug Distributor Accreditation, Track and Trace requirements, and/or Quality Management System experienceThe Nitty Gritty: Manage the maintenance and execution of Policies and Procedures in alignment with FDA, NABP, and state regulations.Create, edit, maintain, distribute and process quality and procedural documents for wholesale distribution operations and trains personnel.Train, support and assist team members in processing quality policies and procedures.Provide specialized training and guidance to staff.Identify, author and/or update SOP's to ensure continued compliance.Complete and assist with facilitation of the timely submissions of initial and renewal license applications for facility and Designated Representatives to appropriate state licensing authorities (including, FDA, State Boards of Pharmacy, and NABP).Assist with the Drug Supply Chain Security Act (DSCSA) traceability documentation and process.Assist with the handling of product recalls.Act as a liaison between facilities and the regulatory department for licensing-related issues, and contribute to applicable communication between parties as necessary.Ensure collaboration and ongoing communication with all applicable internal teams.Support field personnel with issue resolution involving facility and/or materials licensing and registration.Research, record, communicate, and ensure compliance with current and pending Federal, State, and local Wholesale Distribution laws/regulations that impact the shipment of prescription products.Responsible for awareness and action for changes and updates to federal and state license regulations, statutes, requirements and laws as it pertains to state licensing to ensure company compliance.Assist with executing timely prescription product reporting obligations. Assist with preparation of reports and subsequent analysis for operational efficiency regulatory compliance.Effectively interact with both internal and external auditors and with internal company senior leadership.Must be able to work effectively as an individual contributor, as well as a member of the team, and be able to take ownership of their responsibilities with minimal direction.Physical Requirements:The physical demands are representative of those an employee encounters while performing the essential functions of the job.Essential and marginal job functions are subject to modification.Possible travel could occur.Statistics show that women and those in underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Hilco Vision and its subsidiary companies encourage you to change that statistic and apply - regardless of if you think you're the perfect candidate. Rarely do candidates meet 100% of the qualifications. We look forward to your application and commend you for taking the time to apply!

Keywords: Hilco Vision, Fairfield , Quality Assurance/Regulatory Affairs Specialist, Other , Fairfield, Ohio

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