Quality Assurance Specialist
The Quality Assurance Specialist plays a pivotal role in ensuring the smooth operation of engineering systems and processes within our facility.
This position requires strong organizational skills, attention to detail, and effective communication abilities to collaborate with cross-functional teams.
Key Responsibilities:
* Ensure that all engineering activities are conducted in accordance with GMP standards and site quality regulations.
* Oversee equipment qualification, utility validation, facility modifications, and engineering change controls to maintain compliance and efficiency.
* Support the commissioning and qualification lifecycle, including document review and approval of protocols (IQ/OQ/PQ), risk assessments, and summary reports.
* Lead or support investigations related to engineering deviations, non-conformances, and CAPAs, ensuring timely closure and root cause identification.
* Participate in cross-functional project teams for new equipment introduction, process improvements, and site upgrades, embedding quality throughout.
* Act as quality representative within engineering-led initiatives, such as reliability improvements and energy efficiency upgrades.
* Support preparation for regulatory inspections and internal audits relating to engineering systems and GMP compliance.
* Maintain and improve engineering quality processes, including document control, calibration systems, and preventative maintenance compliance.
Requirements:
* Degree in Engineering, Life Sciences, or a related technical discipline.
* 5+ years' experience in a GMP-regulated pharmaceutical, biopharma, or medical device environment.
* Strong knowledge of validation principles, engineering best practices, and regulatory requirements under GMP.
* Hands-on experience with C&Q documentation, risk-based validation, and change management processes.
* Familiarity with engineering systems such as CMMS, BMS, and automated manufacturing equipment is beneficial.