Sr. Supplier Quality & Compliance Specialist

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 eight (8) to ten (10) years' experience within a pharma, biopharma and/or biotech manufacturing environment or five (5) 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

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):

• Establishes strategy and provides oversight for release program across sites for incoming material.
• Owns supplier quality program and supplier quality strategy, including travel to external supplier sites.
• Provides oversight for high-risk investigations and trends supplier performance.
• Provides technical leadership, trends metrics, and drives QMS improvements.
• SME for root cause analysis investigations and systemic problem solving.
• Serves as primary SME for customer and regulatory audits
• Establishes document strategy and ensures alignment with regulations and client expectations.
• Develops oversight strategy and drives compliance initiatives within the warehouse and the weigh & dispense area.
• Acts as primary quality representative for strategic customer relationships.
• Develops continuous improvement strategy and measures effectiveness.
• Provides organizational leadership for strategic quality initiatives

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!