Job Description

Job Summary

Mauricio Ducassi is looking for a Sr. Quality Assurance Associate for a biopharmaceutical client. The Sr. Quality Assurance Associate will be responsible for supporting site management ensuring the site performs in a state of compliance by supporting all Quality Compliance and Inspection Management oversight activities while fostering an empowered culture of quality across all functions.

Responsibilities

• Author, review and approve SOPs, protocols, reports, and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards.
• Assists with continually evaluating Quality Systems and procedures while independently identifying areas for improvement and assisting in the implementation of new practices
• Assists with preparing and providing GMP training to cross-functional departments
• Assists with executing and maintaining internal/external audit programs
• Assists with maintaining the customer audit process
• Assists in the management of all audit and inspection activities (Client, Internal, Regulatory)
• Acts a lead of all backroom activities required to support audits and inspections
• Assists in scribing and sponsors auditors and inspectors
• Coordinate, perform and track risk assessments and site Quality metrics
• Supports discrepancy reports (e.g., deviations, CAPAs, complaints, etc.)
• Assists with executing and maintaining Electronic Management Systems as it relates to Quality
• Communicates effectively with supervisors, colleagues, and subordinates
• Travels as needed to attend audits, professional conferences, and training opportunities
• Remains responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices
• Adheres to quality standards set by regulations and company policies, procedures, and mission.
• Operates to the highest ethical and moral standards.

Qualifications/ Skills Required:

• Minimum of B.S. degree in Life Sciences or related discipline with 5-10 years of experience in a GMP regulated Biopharmaceutical facility or equivalent.
• Knowledge of industry standards and regulation requirements for biologics and parenteral products in clinical development and commercial.
• Knowledge of GMP regulations (US, EU and ROW), good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards, and guidance.
• Detail oriented with strong analytical, written, and verbal communication skills.
• Must be familiar with Microsoft Office applications.
• Ability to work well under pressure, independently, multi-task, be organized and have good communication skills.

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