Specialist, Supplier Quality

Cosette Pharmaceuticals•Bridgewater, NJ

5d•Hybrid

About The Position

Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas. Innovating every day.™ Position Summary 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; advanced degree preferred
3+ years of experience in the pharmaceutical/regulated products industry, with a focus on Quality Control and Quality Assurance.
Support of Regulatory Agency (FDA, EMA) Inspection Experience preferred
Technical Writing
Analytical Methods
Root Cause Techniques
CAPA System
GMP Training
Quality Management Review
Validation Practices
Data Integrity
Quality Management Systems
Analytical Chemistry
External Vendor Auditing Experience preferred
Experience with MS Word, Excel, and Project.
Experience with eQMS required.
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

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