Quality Assurance Engineer

Objective

Under minimal supervision, the Quality Assurance Engineer provides Quality oversight activities for the aseptic fill/finish manufacturing suite. Provide Quality Assurance technical expertise to ensure to ensure aseptic manufacturing facility, processes and support systems are in compliance with company guidelines and CGMP regulations marketed products and/or their raw materials, APIs, excipients or components.

*** Hours are 3am to 11am ***

Essential Functions

• Collaborate with full range of personnel in manufacturing 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 and collateral contacts to correct non-routine and, or comprehensive issues, identify trends and determine corrective actions. Make recommendations that meet technical, regulatory and business requirements.
• Review and approve protocols, validation documents, investigations and procedures both internally and externally.
• Resolve unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on evidence.
• Provide technical expertise in conducting investigations and making recommendations for targeted data and information collection as required for quality events. Contributes to data and information collection.
• Alert management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions.
• Approve change controls and represent Quality in Change Control Board meetings as needed.
• Conduct Pre-op GMP checks.
• Represent QA in a range of team meetings, processes and initiatives both internally and at CMOs.
• Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes 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.

Education/Experience

• BS/BA degree in a scientific discipline with 5+ years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent.

Knowledge/Skill/Ability

• Knowledge of computer systems used for report writing or data presentation (Microsoft Word, Excel, PowerPoint)
• Ability to work in a team-oriented environment and represent the Quality organization on multi-disciplinary teams
• Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies and facilities is preferred
• Ability to recommend and make good decisions in complex situations
• Strong organizational, presentation and communication skills
• Routinely scheduled work, and or overtime work required on evenings, weekends, and or holidays.
• Ability to travel up to 10% domestically.

*** Hours are 3am to 11am ***

Work Environment

The 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.