Quality Assurance Engineer

Provides Quality oversight activities for the aseptic fill/finish manufacturing suite. Offers Quality Assurance technical expertise to ensure aseptic manufacturing facility, processes, and support systems comply with company guidelines and CGMP regulations for manufactured products, raw materials, APIs, excipients, or components.

Responsibilities

• Collaborate with personnel in manufacturing, facilities, inventory, quality control and assurance, supply chain, animal resources, and technical work teams to identify root causes of problems and determine appropriate corrective actions for investigations.
• Consult with internal and external clients to resolve non-routine or comprehensive issues, identify trends, and determine corrective actions 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 recommend targeted data and information collection for quality events.
• Contribute to data and information collection and statistical analysis.
• Alert management of critical issues impacting 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 CGMP compliance.
• Review validation reports, summarize findings, and provide 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 and represent Quality in Change Control Board meetings as needed.
• Represent QA in internal and external team meetings, processes, and initiatives.
• Provide quality oversight support for regulated operations, including review of documentation, compliance monitoring, and QA surveillance activities.
• Actively promote safety rules and awareness, demonstrating good safety practices and reporting hazards.
• Handle and/or be exposed to potentially hazardous chemical, radiological, and/or biological materials, following all safety procedures and using provided protective equipment.
• Perform other duties as required.

Requirements

• 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.
• Understanding of regulatory requirements and quality standards in the pharmaceutical industry.
• Knowledge of risk management, quality by design principles, and statistical analysis (DOE, SPC, ANOVA, etc.).

Skills

• 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.
• Understanding of corporate governance, healthcare 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, utilizing proper lifting and movement techniques.
• Travel up to 10% may be required.

Work Environment

The work environment may involve exposure to radiation hazards. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.