Quality Assurance Engineer

Quality Assurance EngineerThe Quality Assurance Engineer provides Quality oversight activities for the aseptic fill/finish manufacturing suite. Provide Quality Assurance technical expertise to ensure aseptic manufacturing facility, processes and support systems are in compliance with company guidelines and CGMP regulations, manufactured products and/or their raw materials, APIs, excipients or components.Essential FunctionsCollaborate with full range of personnel in manufacturing, facilities, inventory, quality control and assurance, supply chain, animal resources, and technical work teams that support Production to identify root cause of a problem and determine appropriate corrective action for investigations.Consult with a range of internal and external clients to correct non-routine and, or comprehensive issues, identify trends and determine corrective actions. Make recommendations that meet technical, regulatory and business requirements.Perform batch issuance, review and release of clinical drug products and associated records.Provide technical expertise in conducting investigations and make recommendations for targeted data and information collection as required for quality events. Contribute to data and information collection and statistical analysis.Alert management of critical issues that have significant impact related to manufacturing objectives and timelines.Develop, review and approve qualification/validation protocols and reports for facilities, utilities, equipment, processes and systems.Analyze qualification/validation data to ensure compliance with statistically sound, predefined acceptance criteria.Create and Update Quality Assurance and Quality Systems policies and Standard Operating Procedures (SOPs) to ensure compliance to CGMPs.Review validation reports, summarizing findings and providing recommendations for improvements.Conduct cross-functional risk assessments to identify potential quality and compliance issues.Implement and monitor risk mitigation strategies throughout the qualification/validation lifecycle.Ensure all qualification/validation activities comply with relevant regulatory standards.Maintain accurate and comprehensive documentation to support regulatory submissions and audits.Lead and approve change controls related to and represent Quality in Change Control Board meetings as needed.Represent QA in a range of team meetings, processes and initiatives both internally and externally.Provide quality oversight support for regulated operations, including review of documentation, compliance monitoring, and QA surveillance activities, as applicable.Actively promote safety rules and awareness. Demonstrate good safety practices at all times including the appropriate use of protective equipment. Report and take initiative to correct safety & environmental hazards.Handling of and/or exposure to potentially hazardous chemical, radiological and/or biological materials. Required to follow all safety procedures and use personal and protective equipment provided.Other duties as required.Education/ExperienceBS/BA degree in a scientific discipline with 3-5+ years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent.1-2+ years of experience in quality assurance and qualification/validation within a regulated industry (e.g., pharmaceuticals, medical devices, biotechnology).Aseptic fill-finish experience, including familiarity with qualification/validation of aseptic manufacturing technologies and facilities is required.Understanding of regulatory requirements and quality standards in the pharmaceutical industry preferred.Understanding of risk management, quality by design principles, statistical analysis (DOE, SPC, ANOVA, etc…)Knowledge/Skill/AbilityAbility to work in a team-oriented environment and represent the Quality organization on multi-disciplinary teams.Knowledge and experience with GMP, GLP, and GCP requirements.Knowledge of corporate governance, health care regulations, laws, and standards.Strong understanding of quality management systems and (GxP), to ensure compliance with regulatory requirements.Understanding of Facilities, Utilities, and Equipment Qualification and Computer System Validation Assurance requirements.Ability to adapt quickly in a fast-paced dynamic environment.Ability to communicate with and positively influence broad and diverse populations within and outside the organization.Ability to work in a team environment with minimum supervision.Strong collaborative, partnering, and interpersonal skills.Excellent communication skills, both written and oral.High ethical standards, trustworthy, operating with absolute discretion.Highly organized with great attention to detail.Flexibility to work various shifts, as required.Ability to lift up to 50 pounds, to and from a mobile cart, utilizing proper lifting and movement techniques.Travel up to 10% may be required.Work EnvironmentThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. During the course of this job, the employee may encounter exposure to radiation hazards. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.