Manufacturing Coordinator (off shift or weekend)

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's primary responsibilities include the support of sterile operations and coordination of the process of customer manufacturing from documentation preparation to completion of primary packaging. This position is responsible for administrative and logistical tasks to support the production schedule and customer expectations. This position primarily supports the Butterworth facility, and the hours will align with either the off shift or weekend crew.

Non-Negotiable Requirements:

• Bachelor's degree or equivalent training and/or experience.
• Strong operational and tactical orientation.
• Proficient computer skills in Microsoft Word, Excel and Outlook.

Preferred Requirements:

• A thorough understanding of cGMP, FDA/EMA guidelines and multinational regulatory standards is preferred.
• Prior experience working in a fast-paced, emerging growth CMO is a plus.

Responsibilities Include (but are not limited to):

• Work directly with operations Supervisors to support the production schedule by ensuring materials are available, organized and in compliance with GRAM procedures.
• Ensure that products being manufactured are maintained in a manner that supports quality standards, the production schedule, and safety guidelines.
• Prepare and review documentation on the floor including, but not limited to logs, forms, Master Batch Records, equipment reports, and work orders.
• Escalate issues as necessary to ensure that forecasted production plans are properly maintained by identifying shortages in available materials prior to need.
• Maintain, consume and produce proper inventory counts utilizing GRAMs inventory management software.
• Communicate progress of work to shift lead and to evaluate methods for increasing efficiencies.
• Responsible for cleanliness and organization of the production floor on a daily basis as a 5S lead/champion for the team.
• 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.
• Effectively interface with cross functional teams to include MSAT, Quality Assurance, Supply Chain Management, and Validation as it relates to supporting the production floor.

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 13 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: Employees earn 1 hour of time off for every 30 hours worked to use how 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.