The QA Engineer reports to the TaT Quality Director. This is a professional quality engineering position to support the quality assurance activities of the TerraPower radiopharmaceutical Targeted Alpha Therapy (TaT) Program. Initially, this position will assist in developing a Quality Management System to Title 21 CFR 210/211 and ICH Guides. The role will then perform day-to-day oversight for compliance of the quality program.
This position is in a dynamic environment and requires the ability to maintain composure while making important decisions. The position will require good judgement in balancing compliance and business resolutions.
Responsibilities
Read, understand and interpret requirements such as federal regulations, national codes and standards.Develop company Quality procedures compliant to the above standards.Be able to articulate standards to coworkers and suppliers and as necessary train company personnel to quality requirements.Review other TerraPower quality related procedures (engineering, procurement, document control, records, testing).Review procurement specifications, purchase orders, task orders, and agreements for quality assurance requirements.Review design specifications, operational procedures and other technical documents for quality assurance requirements as required or requested by the technical organizations.Plan and/or perform audits, external (supplier) and internal.Support customer audits and performance of supplier audits. Must be able to interface with customer and suppliers regarding requirements during audits, surveys or inspections.
Key Qualifications and Skills
A bachelor level degree in radiochemistry, or a technical discipline, (may consider an exception to the education requirement if the applicant has extensive cGMP/nuclear quality assurance experience) or related discipline.7+ years’ experience in either a quality assurance function or combination of quality assurance (5 years min.) and production role(s) in a regulated operational production environment (preferably cGMP or nuclear)The successful candidate will possess a high degree of trust and integrity, communicate openly and display respect and a desire to foster teamworkThe ideal candidate must have experience working within in a quality program, compliant stringent quality standard(s) such as 21 CFR 210/211 and ICH Guides, Nuclear (NQA-1, 10 CFR 50, App. B, ASME III), Aerospace (AS 9100) or similar; preferably, experience in an operational / production facility.Must have a keen attention to detail with the ability to read, understand requirements such as federal regulations, national codes and standards and interpret these standards into TerraPower documents and provided guidance to TerraPower personnel regarding these requirements.Must have experience with CAPA programs, continuous improvement models and root cause analysis.Experience writing Quality procedures, documents and forms.Shall have experience or possess ability to learn, understand and use various quality support software for records retention, tracking of adverse conditions, document management, forms development, etc.Experience with the audit process is a plus.
Job Functions
Job Functions are physical actions and/or working conditions associated with the position. These functions may also constitute essential functions for the job which the employee must be able to fulfill, with or without accommodation. Information provided below is to help describe the job so that the applicant has a reasonable understanding of the job duties/expectations. An applicant's ability to perform and/or tolerate these actions and conditions will be discussed and workplace accommodations may be made on a case-by-case basis following an individualized assessment of the applicant and other considerations, including but not limited to any governing safety standards.
Motor Abilities: Sitting for extended periods, bending/stooping, grasping/gripping, fine motor control (hands)Physical exertion and/or requirements: Minimal, with ability to safely lift up to 40 poundsRepetitive work: Occasional, prolongedSpecial Senses: Visual and audio focused workWork Conditions: Stairs, typing/keyboard, standard and/or sitting working environment of >8 hrs./dayTravel required up to 15%Category: QA/QC Engineer