Qa Specialist I Jobs

uniQure is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working lives by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

Main purpose of the job

The Quality Assurance Specialist I, supports the day-to-day quality operations via Manufacturing Clean Room presence, Material/Inventory QA Release, oversight of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, change control, batch review, data integrity, and training in support of biologics manufacturing production.

Key Responsibilities:

• Represent Quality Assurance on project teams and in meetings.
• Review, assist in the investigation of, and approve deviations related to Manufacturing operations.
• Support the continuous improvement and oversight of Quality Management System procedures.
• Support cGMP manufacturing operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
• Review and approve batch records and solution lot records.
• Provide on-the-floor QA support for manufacturing activities.
• Support internal and external audits.

Other Requirements:

• A minimum of a Bachelor’s degree in Life Sciences or Engineering
• Position requires incumbent to be capable of lifting 25 pounds and must be able to demonstrate ability to gown aseptically
• Well versed in cGMP/ICH/FDA/EU regulations and guidelines
• Proficient in using Microsoft applications (MS Word, MS Excel, MS Powerpoint)
• Experience working in a GMP manufacturing environment
• 1-3 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment

Core competencies

• Strong communication skills
• Ability to manage multiple activities with challenging timelines
• Strong organizational skill
• Capable of working with minimal supervision
• Ability to work well with diverse groups