Specialist, Supplier Quality

Cosette Pharmaceuticals Inc.•Bridgewater, NJ

20h•$102,000 - $153,000•Hybrid

About The Position

This position is responsible for maintaining Cosette Supplier Management Program under the direction of Supplier Quality Management. Position requires strong influencing skills, risk-based decision-making capability, and a high degree of collaboration and teamwork. The position will support the supplier quality team in collaborating with cross functional teams to onboard new suppliers and maintain current suppliers.

Requirements

Bachelor’s Degree in a scientific/technical discipline
3+ years of experience in the pharmaceutical/regulated products industry, with a focus on Quality Control and Quality Assurance.
Technical Writing
Functional Knowledge: Analytical Methods Root Cause Techniques
CAPA System
GMP Training
Quality Management Review
Validation Practices
Data Integrity
Industry Related Knowledge: Quality Management Systems, Analytical Chemistry
Experience with MS Word, Excel, and Project.
Experience with document control/management in a regulated environment.
Fundamental knowledge of quality systems in regulated environments.
Skilled at organizing information into a clear concise written form and the ability to write for compliance.
Customer focused, initiative, interdependent partnering.
Good organizational and planning skills.
Strong working knowledge of editing, proofreading, spelling, grammar, and punctuation.
In-depth understanding of good documentation practices in a GMP environment.
Ability to make and guide quality/compliance decisions that are data based and commensurate with risk.

Nice To Haves

advanced degree preferred
Support of Regulatory Agency (FDA, EMA) Inspection Experience preferred
External Vendor Auditing Experience preferred
Experience with eQMS required.

Responsibilities

Drive and maintain the Cosette Supplier Management Program to include the following: Supplier records and supplier CAPA, Audits and reporting, Risk assessments, Create and update quality agreements, Perform/support supplier audits, Collaborate with cross functional teams to onboard new suppliers and maintain current suppliers, Maintain metrics for adherence to the supplier audit schedule, Participate in internal, customer, and regulatory audits as needed, Support projects as requested
Travel up to 25%