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 sample coordinator coordinates internal logistics of samples between sites and ensuring traceability during production and support operations. This position will work closely with Supply Chain, Quality, Operations, Continuous Improvement, Validation, MSAT, and Project Management to support site objectives.
Non-Negotiable Requirements:
HS Diploma/GED required.
Passing of post-offer, pre-employment visual acuity test
Must have proficient computer skills in Microsoft Word, Excel, and Outlook.
Preferred Requirements:
Experience working in a pharmaceutical or other regulated environment.
Experience in a warehouse environment, processing orders, or inventory control.
Responsibilities Include (but are not limited to):
Obtain and maintain training on Visual Inspection Operations.
Follow applicable procedures with regard to shipments, operations, quality, compliance, chain of custody, sample retention, sample storage, controlled substance, and GDPs.
Prepare, review, and complete GMP and non-GMP documentation for use in Sample Management including, but not limited to in-process samples, PPQ/ENG samples, media fill samples, incoming samples, finished goods samples, logs, forms, and Master Batch Records.
Escalate constraints and delays timely to mitigate risk to product quality and batch release timelines.
Adhere to established Key Performance Indicators and project timelines.
Demonstrate accurate reject classification of visual inspection defects and appropriate documentation.
Review pertinent sampling documentation (SOPs, protocols, reports, etc.).
Pull samples for testing and storage (e.g. retrieve samples, sample management, etc.).
Complete necessary sampling documents as needed.
Complete inventory transactions for sampling performed.
Assist Project Management and Stability Coordinator on any client sampling requests.
Initiate deviation reports for any applicable nonconformance.
Work closely with respective team members from Operations, Engineering, Maintenance, Project Management and Quality to ensure all documentation (and respective data) is gathered in an expeditious manner for timely completion of sample submissions.
Effective cross-functional collaboration with Operations, Engineering, Maintenance, Project Management, Quality, Operational Excellence, MSAT, and any other pertinent department to ensure all documentation (and respective data) is gathered in an expeditious manner for timely completion of sample submissions.
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. If you meet the required criteria listed above, GRAM welcomes you to apply today!