Quality Assurance Representative

COMPANY OVERVIEW:

Brookhaven National Laboratory is committed to employee success, and we believe that a comprehensive employee benefits program is an important and meaningful part of the compensation employees receive. Review more information at BNL | Benefits Program

ORGANIZATION OVERVIEW:

The Planning, Performance and Quality Management Office (PPQM) provides an enterprise-level perspective on planning and performance and provides a focal point for Laboratory contractor assurance activities. Within PPQM, the Quality Management Office (QMO) works with line organizations on developing and delivering programs, activities, and services that integrate quality assurance, environmental, and safety management principles throughout the Laboratory. Deployed Quality Representatives work closely with their assigned organizations to provide quality assurance functions tailored to the organization and serve as a liaison back to the QMO.

POSITION DESCRIPTION:

The Quality Management Office (QMO) at Brookhaven National Laboratory is seeking a self-starter to join their team as a deployed Quality Representative. As an engineer, you will apply standard quality assurance and quality control practices and techniques in specific aspects of design, procurement, manufacture, test, and initial operation. In this role, you will work with colleagues to support the implementation of quality assurance and quality control methods on projects and processes. Activities include planning, performing, and documenting assessments of processes against requirements; support the implementation of corrective action plans, analyzing performance data, performing supplier reviews and selections and incoming inspections, managing calibration programs, and developing and reviewing procedures.

This position will directly support the Isotope Research & Production Department (IP) within the Nuclear and Particle Physics (NPP) Directorate via a Service Level Agreement (SLA) while maintaining an effective interface with the QMO.

Essential Duties and Responsibilities:

• Develop, implement, and maintain Quality Assurance (QA) systems and procedures, including design control, process control, process validation, discrepancy reporting, calibration, and inspection/testing in compliance with Good Manufacturing Practice cGMP Q7, ICH Q10, 21 CFR 830, 21 CFR 210, 21 CFR 211, and Drug Master File requirements.

• Provide input on the conduct of assessments, reporting and evaluation of assessment results, and provide support for external assessments.

• Assist with or conduct causal analyses, and extent of condition/cause evaluations.

• Provide corrective action management, including the timely development and implementation of effective corrective action plans, provide independent verification of corrective action implementation resulting from internal and external assessments, causal analysis, and surveillances.

• Review procurement requisitions to ensure proper flow down of quality requirements

• Perform supplier evaluations, address suppliers' non-conformances, audit suppliers, and support the performance incoming inspection/testing and acceptance.

• Review/approval of technical documents (e.g. drawings, engineering change requests, statements of work, specifications, procedures) to ensure appropriate quality requirements have been addressed.

Required Knowledge, Skills, and Abilities:

• Bachelor's degree in engineering or scientific discipline or closely related field of study.

• Knowledge of basic quality assurance and quality control methods.

• Minimum of 3 years of progressively responsible, QA related experience in an FDA-approved manufacturing environment

• Experience in an engineering and manufacturing environment supporting FDA regulations and process validation.

• Excellent written and verbal communication and interpersonal skills required to interact with a diverse group of engineers, scientists and technical staff.

• Working knowledge of QA systems and their implementation, as well as engineering drawings and manufacturing processes in support of a cGMP-approved process and supporting FDA and customer audits.

• Core skills include organizational and time management, ability to gather information and resourcefulness in resolving problems.

• Ability to work independently, make informed decisions, and exercise a high degree of discretion and judgement.

• Desire and ability to learn new systems.

• Proficient in the use of Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint) and Microsoft Visio.

Preferred Knowledge, Skills, and Abilities:

• 7 years relevant work experience

• Knowledge of or training in specific quality standards or skills (e.g., ISO9001, ASME NQA-1, ASQ Certification, Auditing).

• Willingness to work in a manufacturing environment

• Familiarity with FDA process validation guidelines.

• Understanding of isotope manufacturing processes.

• Knowledge of SPC, FMEA, and trend analysis.

• Engineering Degree in a Chemistry-related field is a plus.

Additional Information:

• On-Site Position

Brookhaven Laboratory is committed to providing fair, equitable and competitive compensation. This is a multi-level role and the full salary range for this position is $92300 - $140000 / year. You will be placed at the level and salary commensurate with your experience. Salary offers will be commensurate with the final candidate's qualification, education and experience and considered with the internal peer group.