Beacon Hill Pharma is currently hiring a Quality Specialist for a direct opportunity in the Greater Boston area .
Key responsibilities: Acting as a point of contact for issues relating to QA from customers and project teams. Draft, negotiate and complete quality agreements with customers. Support regulatory inspections and audits. Manage any outcomes/findings, ensure appropriate responses and escalate if necessary. Plan, execute the annual internal audit plan and for cause audits, report and escalate major and critical non-compliance issues. Provide QA support to initiate, participate and contribute to process improvements projects. Apply GMP regulations consistently and use knowledge of GMP and quality processes to actively identify and participate in continuous improvement activities. Identify opportunities for GMP compliance training and awareness campaigns - design, develop and deliver. Mentor others to expand on-site compliance knowledge.
Requirements: At least BSc in Science 2 years plus of Quality Management Experience in a GMP environment Biologicals, reagents and biopharmaceuticals experience Experience working with drug substances Excellent communication skills (verbal and written) Excellent risk based decision-making and problem solving skills. Ability to meet strict deadlines. Ability to work in team and solo capacity. Significant experience in risk management and project management. Strong computer skills in Microsoft office, Excel, Power point and Word Strong communication/inter-personal skills - need to be diplomatic, dynamic, a fast leaner, resilient and change management.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.