GMP Material Specialist II

AGC Biologics

AGC Biologics

Bothell, WA, USA
Posted on Tuesday, September 17, 2024

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

SUMMARY:

The Materials Control Specialist II will work collaboratively with others, performing various Good Manufacturing Practices (GMP) Warehouse processes. The ideal candidate possesses strong multi-tasking skills, strong verbal and written communication skills, and experience working in a fast-paced, dynamic environment with limited supervision. Provides exceptional service to our customers, internal and external.

PRINCIPAL RESPONSIBILITIES:

  • Quality is the responsibility of each employee. Each employee is expected to perform his/her tasks diligently and in compliance with requirements in the Quality System.
  • Performs timely and accurate transactions in ERP and related inventory/data management systems.
  • Support monitoring, ordering, and handling of supplies and materials used in facilities and manufacturing operations.
  • Dispenses materials to support manufacturing, including handling hazardous materials, detailed measurement/portioning, performing aseptic technique in a clean room setting.
  • Helps organize and clean warehouse, ensures material identification, status, location, movement, and quantities are accurate, timely, and correct.
  • Conducts cycle counts, researches inventory discrepancies and performs year-end physical count.
  • Understands and adheres to SOPs and cGMP compliance regarding materials control in multiple storage locations and conditions.
  • Regularly generates process improvement suggestions to support key initiatives proposed by management.
  • Ensures warehouse safety standards are upheld, and notifies management staff of any issues, observations, or concerns regarding violations, or potential enhancements to department safety. Generates Job Safety Analysis suggestions, and performs/owns maintenance events as directed by BMRAM system and management.
  • Participates in training new employees in key department processes.
  • Participates in department maintenance, equipment maintenance, and upkeep activities.
  • Handles key inventory item processing; API, Cell Banks, Vial Pulls, shipping activities, and verifications.
  • Other duties as assigned.

KNOWLEDGE, SKILLS & ABILITIES:

  • Ability to complete HAZMAT training, a requirement of performing portions of the work.
  • Ability to operate hand truck, lift trucks, and other equipment.
  • IATA and/or hazardous goods handling certifications completed or ability to immediately begin training and qualification and shipping training.
  • Ability to communicate clearly and interact constructively with peers.
  • Basic computer literacy and ability to perform accurate transactions.
  • Basic mathematical skills.
  • Ability to lift up to 40 pounds, with or without assistance of tandem lift or other materials handling equipment.
  • Good attention to detail with strong organizational skills.

EDUCATION/EXPERIENCE:

  • Minimum High School diploma or equivalent.
  • Minimum two years of experience handling and transacting lot-controlled inventory (preferably in a GMP environment).
  • APICS, NAPM, or CLM certification or equivalent training a plus.
  • Experience with inventory management systems.
  • Ability to lift up to 40 pounds with or without the assistance of tandem lift or other materials handling equipment.

Compensation

$21.19 - $29.14

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.