Supplier Quality & Compliance Specialist III

Description

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!

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. Responsibilities include facilitation of incoming materials and release activities; supplier quality oversight, including supplier related investigations and corrective actions; warehouse quality oversight; and support of manufacturing operations, including weigh and dispense activities. This position provides guidance for quality system processes, including deviations, CAPA, change control, SOP development and revision, quality document review, and overall Quality Management System (QMS) effectiveness.

Non-Negotiable Requirements: 

• Bachelor’s degree in Life Sciences.
• Minimum five (5) to eight (8) years’ experience within a pharma, biopharma and/or biotech manufacturing environment or four (4) years of experience with Certified Quality Auditor (CQA) certification 
• Ability to obtain applicable professional certifications (e.g., ASQ Certified Quality Auditor) within a reasonable timeframe. 

Preferred Requirements

• Aseptic manufacturing experience

Experience executing the following:

• Supplier Quality Management 
• CAPA, Deviations, Change Control 
• Audit and regulatory inspection support 
• Technical writing 
• Root cause analysis (RCA) 

Responsibilities Include (but are not limited to): 

•  Serves as technical resource for complex incoming material release decisions and mentors others. 
•  Leads supplier qualification strategy, complex suppliers, and risk assessments. Performs on-site audits 
•  Leads complex investigations involving multiple stakeholders and suppliers.
•  Leads complex quality events and provides guidance to others. 
•  Facilitates complex cross-functional investigations and RCAs. 
•  Leads audit preparation and represents Quality during inspections. 
•  Reviews complex procedures and provides technical recommendations. 
•  Leads improvements and provides guidance to operations. 
•  Leads customer quality initiatives and difficult client interactions. 
•  Leads cross-functional improvement projects. 

Full job description available during 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!