Quality Assurance Specialist

BioHybrid Solutions (BHS) is looking for a Quality Assurance Specialist that will report to the Vice President of Quality and Operations.

• Supports the development of the Quality Plan for cGMPs and ensures deployment as approved by BHS senior management.
• Responsible for supporting and leading quality oversight for components and/or products manufactured by external contract manufacturing organizations (CMOs), including audits, quality assurance, quality control and analytical issues.
• Supports and leads the deployment and implementation of GxP practices, policies, and procedures within the BHS laboratory.
• Leads quality events including change control and incident reporting. Lead root cause analysis investigations and develop CAPA for continuous improvement.
• Work with BHS’s analytical team to support design of experiments (DOEs), qualification studies and phase appropriate validations.
• Supports and takes ownership of the electronic Quality Management System which include controlled documents, training, change control, Incident Reporting and CAPA.
• Support vendor qualification.
• Develop and implement quality indicators to trend the quality programs success.
• Lead quality discussions on a weekly basis.
• Support the build out of a strong quality culture.

Required Qualifications:

• B.S. or M.S. degree in the Life Sciences (or equivalent) with knowledge of current Good Manufacturing Practices (cGMP)
• 2-3 years of experience with reviewing protocols, batch records and SOPs.
• 2-3 years of experience with conducting and/or directing audits and inspections.
• Proficient written and oral communication skills.
• Leadership abilities with strong problem-solving ability.
• Well organized and methodical.
• Ability to effectively communicate expectations.
• Ability to gain acceptance of an idea, plan, or activity.
• Ability to interact with technical staff at all levels in a team-based environment.

Physical Requirements:

• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.
• Ability to navigate a laboratory facility.