Overview

GMP/DEA Compliance Coordinator

Levittown, PA

Direct-Hire Opportunity

Full-Time, Dayshift

Kelly Science & Clinical is interviewing/hiring immediately for a GMP/DEA Compliance Coordinator! This is a great fit for someone with previous GMP/DEA experience with strong attention to detail, documentation skills, and adherence to various regulations. This team is looking for someone with a positive-attitude and self-motivation who is looking to grow long-term with a rapidly growing team.

Job Description: The Compliance Coordinator is accountable for the site activities related to DEA controlled substances as well as ensuring site compliance with DEA Regulations and Company SOPs. The DEA Associate will report to the Head of QMS and Compliance and efficiently conduct all duties and responsibilities assigned and or delegated by the Head of QMS and Compliance.

Responsibilities
• Manage receipt, storage, dispensing, shipment, and record keeping of controlled substances
• Maintain DEA Registrations for the site including those for R&D and Analytical departments and provide support during DEA audits and inspections.
• Maintain list of authorized personnel
• Preparation, maintenance, shipping and ordering of DEA 222 form.
• Coordinate controlled substance destruction with Reverse Distributor.
• Manage physical inventory counts (i.e. Biennial, Mid/Year-End).
• Manage the completion and submission of required DEA records and reports for controlled substances: ARCOS Reports, Year End Reports, Quota Submissions, Import/Export Applications, SOP’s.
• Conduct periodic internal audits of manufacturing and analytical departments for continuous improvement of the CS process and ensure regulatory compliance with 21 CFR (Part 1300 – End).
• Assist in conducting Due Diligence within the Order Analysis System, company partners and customers.
• Maintain documentation to support DEA inspection-readiness (i.e., API/batch reconciliations).
• Receipt, log-in and inventory control of DEA related API’s, excipients, reference standards and raw materials.
• Understands timelines and demonstrates a sense of urgency in work and in responding to colleagues.
• Proactive, good organizational and time management skills
• Follow and enforce GMP and DEA practices and applicable Standard Operating Procedures. Report any concerns immediately to the management.
• Assist with training of new and current employee on DEA responsibilities and participate in department or company projects/initiatives as requested.
• Interact with any and all other departments to resolve any issues regarding DEA materials
• Other duties may be assigned by the Head of QMS and Compliance, or Site Head of Quality

Qualifications:
• Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word.
• Strong organizational skills and the ability to multitask
• Demonstrated ability in working independently and as part of a team.
• Must be able to work in a cross-functional environment interacting with other internal departments and external vendors
• Excellent communication (oral and written) and interpersonal skills
• Knowledge of cGMPs and DEA regulations (CFR Part 1300 – End). Knowledge of liquid processes preferred.
• Ability to work evenings, weekends, holidays, and on-call.

Education and/or Experience Requirements:
• Bachelor’s degree
• Minimum of three (3) years of experience working in a GMP environment.
• Minimum of three (3) years of experience in a pharmaceutical environment handling DEA material.

Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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