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 apply to join our community of dedicated individuals improving lives every day!

NON-NEGOTIABLE REQUIREMENTS:

• Bachelor’s Degree, preferably in Life Sciences field, or 5 years of equivalent experience.
• 3 years of leadership experience.
• 5 years of experience in regulated cGMP environment.
• Previous sample management or logistics experience with raw materials, components, finished goods, and stability.
• Proven experience with various computer software applications to track and trend quality metrics (e.g. Microsoft Office, LIMS, and inventory systems).

PREFERRED REQUIREMENTS:

• Thorough understanding of cGMP, FDA guidelines and multinational regulatory standards.
• 5-7 years of leadership experience.

• Develop, implement, and sustain a scalable system for sample logistics and traceability across GRAM’s GMP facilities. Sampling activities include, but are not limited to: sample execution, sample approval, documentation preparation, internal/external logistics, timeline management with adherence to batch release timelines, investigation support, coordinating cross-functional activities, and reconciliation.
• Provide leadership and prioritization to sample coordinators and associates for executing sample activities at GRAM.
• Oversee receipt, labeling, storage, and distribution of all samples (PPQ, ENG, COM, component, raw materials, finished goods, bulk product, stability, in-process, etc.).
• Maintain compliant documentation and traceability of samples throughout the sample lifecycle in accordance with cGMP, FDA, EMA, and other regulatory agency requirements.
• Ensure support and oversight of sampling across three shifts, including occasional weekend support, for multiple manufacturing facilities.
• Act as sampling SME during review and approval of sampling related documents (specifications, protocols, templates, forms, MBRs, etc.).
• Work closely with Quality Control, Quality Assurance, Manufacturing, MS&T, Validation and Supply Chain operations to facilitate sampling operations.
• Review, assess, and approve various Quality Management System functions, including, non-conformance reports, change controls, QAD transactions, area clearances, etc.
• Author and maintain pertinent sampling documentation (SOPs, protocols, templates, forms, etc.).
• Obtain and maintain training on GMP sampling and sample management.
  Full job description available during formal interview process.