Quality Assurance Engineer

Quality Assurance Engineer

The 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.

• Collaborate 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.

• BS/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…)

• Ability 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.

The work environment…