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Quality Assurance Associate
2 weeks ago
We are seeking a highly skilled Quality Assurance Associate to join our team.
Job DescriptionThe successful candidate will be responsible for providing quality oversight for all validation activities in a regulated environment. This includes the implementation, requalification and decommissioning of manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment.
The key responsibilities of this role include:
- Providing quality oversight for FUE activities related to products and facilities.
- Supporting the development of validation plans for specific system implementation projects.
- Reviewing and approving project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols) validation activities related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions.
- Maintaining current knowledge of industry standards and regulatory requirements for products developed or manufactured by Bio Marin, validation techniques/approaches and systems utilized at Bio Marin.
- Leading and representing QA Validation in multi-departmental meetings & project teams.
To be considered for this role, you must have a Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences). You must also have +3 years' experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems/validation.
A high level of initiative, energy and motivation are key requirements for this role, as well as organizational skills. The ability to speak, present data, and defend approaches in front of audiences and inspectors is also essential.
You should have understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations. Proficiency with technical summary report generation is required, with exceptional organizational, spelling, grammar, and typing skills preferred.
