Senior Specialist, Quality Assurance

Essential Duties and Responsibilities

• Perform Good Manufacturing Practice documentation review and approval for internal or outsourced manufacturing of clinical supplies including batch records, deviation and/or out-of-specification approval, change management approval, etc.
• Accountable for all assigned projects and communication of status to the Management team.
• Identify need for and/or develop Standard Operating Procedures to ensure practices are accurately reflected.
• Assist in Standard Operating Procedures and quality-related system development and approval.
• Prioritize work for assigned projects including clinical supply disposition commitments and maintenance of a current Good Manufacturing Practice posture within Global Development Quality.
• Adhere to Good Manufacturing Practice and Standard Operating Procedures.
• Identify and implement continuous improvement initiatives and action plans.
• Assist in preparations for regulatory agency inspections.
• Ensure procedures are followed and specifications met to release or reject materials.
• Build collaborative working relationships and effective communications with all stakeholders in manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels.
• Establish, educate, and enforce standard operating procedures required under Good Manufacturing Practice.
• Participate in investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.
• Maintain a state of readiness for and participate in audits and inspections.
• On-site support of production facility & staff (minimum 60% on a weekly basis).

Education Minimum Requirement

B.S. in appropriate Science or Engineering discipline (chemistry, biology, biochemistry, microbiology).

Required Experience, Knowledge, and Skills

• 5 years of experience in the pharmaceutical or related industry.
• Understanding of current Good Manufacturing Practices and Good Documentation Practices and related drug regulation requirements, including European Union.
• Experience in one or more functional areas such as quality control, quality assurance, analytical laboratories, manufacturing, production support area, clinical development.
• Attention to detail, flexibility, and an awareness of production and associated quality problems.
• Strong interpersonal skills including verbal and written communications, collaboration, teamwork within and across functions, conflict resolution.
• Demonstrated ability to manage multiple projects and priorities simultaneously, and to meet deliverables and timelines.

Preferred Experience and Skills

• Sterile dosage drug product (vial, syringe, other) manufacturing and/or analytical testing.
• A combination of experiences in quality assurance plus operations, laboratory, or related functional roles.
• Experiences in a Good Manufacturing Practice environment including batch production record development, review, or approval, ancillary batch related records, standard operating procedures, work instructions, raw materials, deviations, change control, corrective actions, preventive actions, out of specification results, cleaning, validation plans or protocols, equipment qualification, audits, electronic inventory systems, quality management systems.
• Ability to identify, focus, and solve problems in a timely and efficient manner.
• Experience with quality audits and EU regulatory inspections.
• Experience or working knowledge of Research & Development or clinical supply areas and processes.