Manufacturing Coordinator II

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Benefits starting day 1

401(k) vesting

Volunteer time

PTO + WTO

Paid holidays

Competitive pay

Job summary

Grand River Aseptic Manufacturing seeks a Manufacturing Coordinator II to support sterile operations and coordinate the customer manufacturing process from documentation to packaging. The role is based at the Butterworth facility, on 1st shift, and includes administrative duties to back the production schedule and meet customer expectations.

The position requires a bachelor’s degree or equivalent, strong computer skills (Word, Excel, Outlook), and knowledge of cGMP/regulatory standards.

Qualifications

• Bachelor's degree or equivalent training and/or experience.
• Strong operational and tactical orientation.
• Thorough understanding of cGMP, FDA/EMA guidelines and multinational regulatory standards.
• Proficient computer skills: Word, Excel, Outlook.

Responsibilities

• Support production schedule by ensuring materials are available and compliant with GRAM procedures.
• Maintain product quality, schedule, and safety guidelines on the floor.
• Prepare and review Master Batch Records, logs, forms, equipment reports and work orders.
• Escalate shortages to maintain forecasted production plans and inventory counts in GRAM systems.
• Coordinate and track logistics of equipment (dedicated, support, non-dedicated).
• Interface with MSAT, Quality Assurance, Supply Chain, and Validation to support the production floor.

Skills

Operational orientation

Education

Bachelor's degree or equivalent

Tools

MS Word

Excel

Outlook

Job description

Description

Manufacturing Coordinator II

Agility, Impact, Methodology. Do you exhibit these values and wish to be around others that do too? Do you thrive in fast-paced environments where agility, adaptability, and high standards go hand in hand? Are you driven to make a meaningful impact, whether through your work, your support of others, or your commitment to your community? Are you motivated by a disciplined, science-based approach that ensures consistent excellence, safety, and integrity in everything you do? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to join our community of dedicated individuals improving lives every day!

Overview of this Position:

The Manufacturing Coordinator II'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. The primary location for this position is the Butterworth facility, on 1st shift.

Non-Negotiable Requirements:

• Bachelor's degree or equivalent training and/or experience.
• Strong operational and tactical orientation.
• A thorough understanding of cGMP, FDA/EMA guidelines and multinational regulatory standards.
• Proficient computer skills in Microsoft Word, Excel and Outlook.

Preferred Requirements:

• 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 proper inventory counts utilizing GRAMs inventory management software.
• Confer with department supervisors to determine progress of work 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. 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.
• Coordinate and track logistics of equipment (dedicated, support, non-dedicated).
• Ensure that filling line and support equipment (formulation vessels, pumps, etc) are maintained in a state of compliance by ensuring PMs, calibration, and cleaning is completed per procedure and are available for use and staged at appropriate location prior to batch execution.
• Perform picklist transactions with the Supply Chain team to ensure materials are released and picked to support production.
• Complete off the floor MBR review for completion and quality prior to hand off to QA team.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

BENEFITS starting day 1: Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion 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!

PAID TIME OFF: You choose how to use this time for your vacation, sick, or mental health needs! PTO: Full-time employees accrue up to 104 hours of paid time off per calendar year, with this amount being prorated your first year. WELLNESS TIME OFF (WTO): In addition to PTO, employees earn 1 hour of wellness 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.