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 in Life Sciences or applicable relevant experience.
• QA/QC professional with a minimum of 5 years’ experience within a pharma, biopharma and/or biotech manufacturing environment.
• Must have proficient computer skills in Microsoft Word, Excel, PowerPoint, and Outlook.

PREFERRED REQUIREMENTS:

• Certified Quality Auditor (CQA) certification preferred, or the ability to study, test and receive certification quickly.
• Experience in an aseptic manufacturing environment.

• Support quality systems that may include Regulatory Surveillance, Annual Product Reviews, Controlled Substance Program, customer complaints, internal audits, and external audits.
• Supports work such as assisting with preparation, review and drafting of annual product reviews; Coordinating routine DEA inventory assessments; Reporting annual controlled substance inventory to the state of Michigan.
• Actively host client and prospective client audits, which may include coordinating requests, preparing subject matter experts for interviews, delivering GRAM welcome presentation, discerning and communicating the focus of the auditors, capturing dialogue/notes during audit, preparing and following up on audit responses to clients.
• Actively support regulatory inspections as preparation coordinator. Respond to, coordinate and fill requests, organize SMEs in support of regulatory inspections.
  Full job description available during formal interview process.