Description
Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day.
Overview of this Position:
The Manufacturing Coordinator supports sterile manufacturing operations and coordinates the process of customer manufacturing from documentation preparation to completion of primary packaging. Position is responsible for administrative and logistical tasks to support the production schedule and customer expectations. This position supports 2nd and 3rd shift activities and must maintain the flexibility to do so.
Non-Negotiable Requirements:
Bachelor's degree or equivalent training and/or experience is necessary. Candidate must have strong operational and tactical orientation.
A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is required.
Must have proficient computer skills in Microsoft Word, Excel and Outlook.
Preferred Requirements:
Prior experience working in a fast-paced, emerging growth CMO.
Experience and expertise in aseptic manufacturing of regulated products.
Responsibilities Include (but are not limited to):
Work directly with Operations Supervisors to support the production schedule.
Prepare and review documentation for use in Manufacturing including, but not limited to logs, forms, Master Batch Records, and work orders.
Schedule and coordinate flow of work within or between departments of manufacturing to expedite production.
Confer with department supervisors to determine progress of work and to evaluate methods for increasing efficiencies.
Complete administrative documentation for new employees (training request forms, request for IT accounts, etc.).
Perform administrative duties to support the production schedule for both Butterworth (primary) and Front (secondary) drug product manufacture. This includes preparing of tray tags, requisition of MBR pages, preparation of documentation for transfer of product between facilities, preparation of API dispense documentation, submission of pages to QC, and other administrative duties as assigned.
KPI tracking/monitoring and reporting, including batch data trending, intervention tracking, and other operational trending.
Perform required transactions in Inventory Management System.
Coordinate and track logistics of equipment (dedicated, support, non-dedicated).
Full job description available during formal interview process.
What Sets GRAM Apart from Other Employers:
MEDICAL BENEFITS starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!
Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!
PTO: Full-time employees accrue up to 17 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!
WELLNESS TIME OFF: We offer all employees one (1) paid day of Wellness Time Off (WTO) per quarter to invest in self-care, take some downtime, or whatever you choose.
PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!
PAY: Depends on Experience and is discussed during the interview process.
If you meet the required criteria listed above, GRAM welcomes you to apply today!
GRAM supports Equal Opportunity Employment
