Quality Assurance Specialist Jobs

About The Position

Requirements

• Bachelor's degree.
• Three or more years of quality experience is preferred, preferably in a GMP-regulated environment.
• Ability to access aseptic processing areas; sterile gowning is required for relevant work.
• Exceptional eyesight and sampling technique for AQL sampling activities.
• Ability to analyze complex data and identify trends, issues, and solutions.
• High accuracy and attention to detail in quality assurance activities.
• Strong verbal and written communication skills for interacting with team members and regulatory bodies.
• Ability to identify problems and implement effective corrective actions.
• Ability to manage multiple projects simultaneously and complete them on time while meeting quality standards.

Responsibilities

• Maintain inspection readiness and ensure audit observations are addressed and completed on time.
• Provide daily floor coverage to support production, development, and testing compliance; audit functional areas against cGMP, regulatory, and internal requirements.
• Perform Parallel and CCA Sampling as required by the business.
• Conduct cGMP audits, identify and communicate compliance deficiencies, recommend corrective actions, and monitor compliance with functional area management.
• Complete risk assessments and minor and major incident investigations for unexplained manufacturing events and out-of-specification laboratory results; guide investigation teams.
• Manage the CAPA system, ensure actions are completed on time, and recommend CAPAs for process improvement.
• Support the Change Control System by providing assessments, closure, and monitoring, and recommending documentation and supporting data to evaluate cGMP impacts and mitigate risk.
• Provide final signatory review of SOPs, SWIs, and Master Manufacturing Records for compliance.
• Communicate cGMP requirements and coordinate with site counterparts on manufacturing, testing, disposition, and cold-chain documentation.
• Interact with internal and external audit bodies and present or explain processes and documentation to auditors.
• Request corrections when GMP rules are not followed; prioritize quality and compliance; implement remediation from audit findings; request quality improvement initiatives; identify discrepancies and corrective or preventive actions; and escalate shop-floor GMP failures.
• Inform relevant stakeholders of quality performance, findings, and corrective and preventive measures; advise on presentation of topics, risk management, and initiatives that promote a quality-focused culture.

Benefits

• Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Company employee benefit programs may be available to eligible employees.
• Rewards package recognizing employee contributions.