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
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.