Supplier Quality & Compliance Specialist I

Description

Agility, Impact, Methodology. 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:

This position provides support for Supplier Quality, Incoming Material Quality, Customer Quality activities, and Regulatory Compliance while also supporting manufacturing operations and continuous improvement initiatives. It is responsible for ensuring effective execution and compliance of quality systems supporting the manufacture, testing, and release of cGMP drug products.

Non-Negotiable Requirements:

• Undergraduate Degree in Life Sciences or related field.
•  0–2 years of experience in pharmaceutical, biotechnology, medical device, or other regulated industry. 
• Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.

Responsibilities Include (but are not limited to):

• Perform the quality release of incoming materials, including APIs/RMs/Components. 
• Supports supplier qualification activities and documentation.
• Participate in supplier investigations and data collection. 
• Supports quality records and assigned actions within the quality systems.
• Participates on root cause analysis investigation teams. 
• Supports Regulatory and supplier audits by gathering documentation 
• Reviews routine SOPs and documents. 
• Performs routine quality oversight activities within the warehouse and regarding weigh and dispense. 
• Supports customer requests and quality agreements. 
• Participates in continuous improvement initiatives. 
• Participates as team member on cross functional projects.
• On-Call Support
• Perform all other tasks, projects, and duties as assigned.

 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!

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!