QC Coordinator

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This position supports commercial manufacturing and the QC testing labs by managing the delivery and storage of samples. Sample types may include release test, backups, retains, reference material, assay controls, and stability. Support and maintain retain program as required by regulatory agencies and Boards of Health. Monitoring of environmental chambers is also critical to the storage of the above sample types.

• Coordinate receipt and delivery of samples from designated sample ports to QC laboratories or QC cGMP areas and maintain the inventory for retain samples, backup samples and reference material.
• Adhere to Good Manufacturing Practices (cGMP) and proper documentation practices with generating, reviewing, and reconciling department records.
• Utilize sampling plans effectively and report any problems or adverse quality events to the management and Quality Assurance.
• Maintain sample inventories; and monitor and maintain QC Cold storage units. Perform space evaluations for receipt of material.
• Assist in sampling for laboratory control testing, stability testing, and other special purposes.
• Data entry and distribution of inventory reports.
• Participate in on-call program - Be part of the rotation for the on-call program to support critical equipment 24/7.
• Coordinate and maintain Standard Operating Procedures (SOPs) within the Document Management System (DMS).
• Meetings - Represent the functional group at meetings related to projects, investigations or issues.
• Investigations - May attend meetings for investigations.
• Undertake other duties related to Quality Control or special projects as assigned, manage personal time and growth, and participate in process improvement teams.
• May cross train and provide support for other areas, such as QC Biological Shipping and Receiving, QC Sampling Operations, Solutions Chemistry, and QC Stability Operations.

• Required:
  
  High School Diploma or GED.
• Required:
  
  Ability to multi-task across various capabilities and functions while managing competing priorities and requirements.
• Required:
  
  Effective interpersonal and communication skills.
• Required:
  
  Working knowledge of Microsoft Office applications.
• Required:
  
  Ability to work effectively in a collaborative team environment.
• Preferred:
  Familiarity with Quality Tracking Systems.
• Preferred:
  Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.
• Preferred:
  Biotechnology Certificate.
• Preferred:
  Labware LIMS Experience.
• Preferred:
  Experience working in a GMP facility.
• Preferred: IATA and 49 CFR certification.

• Data entry and reporting of inventory.
• Inventory management and monitoring of QC cold storage units.
• Adherence to cGMP and documentation practices.
• Proficiency with Microsoft Office applications.
• Coordination of SOPs and use of the Document Management System (DMS).
• Strong interpersonal and communication skills and ability to work in a collaborative team.
• Ability to follow sampling plans and report quality events to management and Quality Assurance.

• Non-Standard Work Schedule, Travel, Or Environment Requirements: 1st shift, Sunday through Thursday (weekend differential applies). Some holiday coverage required.
• Physical/Mental Requirements:
  Ability to lift up to 50lbs (assisted); 50-75% of time standing and/or walking.