Quality Assurance Associate
BioMedica Diagnostics is actively seeking a Quality Assurance Associate to fill this role in our growing organization.
This is a great opportunity for a hands-on and multi skilled individual capable of working as part of a dynamic team. BioMedica has experienced significant change and growth in recent years as it works towards consolidating its US and Canadian operations at one facility in Windsor, Nova Scotia. We are seeking someone with a strong QA background in a GMP environment. This role offers the successful candidate a voice in the company, variety, challenge and significant opportunities for professional growth.
• Under the role, the Quality Assurance Associate will be responsible for (but not limited to) the following endeavours:
Implement, Manage and Maintain overall Quality System to include but not limited to, audits, CAPAs, supplier maintenance, document control, and continuous improvement
• Represent BMD in customer and regulatory audits
• Ensure implementation and maintenance of quality control program including but not limited to instrumentation qualification, calibration and maintenance, product testing and release procedures
• Assist in operational SOP revisions and maintenance
• Assist in development of validation protocols
• Assist in other areas of site operations as needed.
• Excellent communication, presentation, writing and editing skills
• Other duties as required
• University degree in Sciences, and/or related experience
• Minimum 3-5 years as a QA in a GMP environment.
• Strong analytical and research skills
• Strategic thinking & strong problem-solving skills
• Excellent communication skills; both oral and written
• Experience with Business Intelligence Tools
• Proven ability to deal productively and professionally with internal stakeholders with a view to facilitating change
• Driven and multi skilled individual capable of working in a fast-paced environment.
• High level of motivation and energy
• Ability to work in a team environment
• Ability to make independent, educated decisions
• Details and results oriented
Skills considered an asset:
• Knowledge and understanding of cGMP and ISO 13485 guidelines and policies
• Project management skills
• Strong interpersonal skills
• Observant and resourceful