Responsible for maintaining and implementation QA requirements site-wide. Responsible for project and sample management responsibilities as they arise for the project. Take appropriate measures to ensure the fulfillment of the quality objectives of management. Enforce QA policies ensuring accuracy and precision of data produced.
ESSENTIAL JOB FUNCTIONS:
- Develop and continually monitor the progress of conditions and best practices to define, measure and improve already established QA processes at the Luckey Site.
- Provide consultation and management of off-site project management, sample processing, data tracking and management, verification and validation, project monitoring and control of samples throughout the life of the project.
- Responsible for maintaining and implementation of QA requirements for the AAR on-site laboratory and off-site laboratory analytical support services contracts.
- Responsible for training subordinates in quality systems and applications.
- Review and approve all procedures, SOWs and SOPs as they pertain to Luckey and used as part of the laboratory QA program and analytical procedures used by the laboratory.
- Monitor QA activities of the laboratory to determine conformance with authorized policies, procedures and governing regulations; make appropriate recommendations for correction and improvement as necessary.
- Monitor sample packaging, shipping, handling and storage activities.
- Manage inter-laboratory testing programs.
- Provide oversight of correction actions and ensure follow through.
- Provide oversight of performance evaluation (PE) analysis.
- Monitor performance of QA and QC audits.
- Monitor data being entered into LIMS.
- Reports to and receives minimal direction from the AAA Vice President – Lab Services and/or AAA Lab Manager.
- Maintain independent authority regarding QA oversight and implementation of the QA program.
- Interface with the AAR Luckey Site Lab Manager and AAR Management, laboratory staff members, corporate senior management, clients and auditors.
While performing the duties of this job, the employee is exposed to normal office conditions and laboratory environments with possible exposure to environmental, chemical and radioactive hazards, odors and loud noise.
SKILLS & ABILITIES:
- Must possess excellent math skills and computer skills (including advanced ability with Microsoft Office (Word, Excel, PowerPoint, Visio) Adobe Acrobat, and database construction and maintenance).
- Must possess effective written and verbal communication skills.
- Ability to prioritize and re-prioritize tasks.
- Ability to work in a high-stress environment.
- Ability to perform multiple tasks at one time.
- Ability to work with limited supervision.
- Ability to read and understand federal, state and local regulations and guidelines as they apply to quality assurance/quality control.
- Ability to learn new methods and systems.
- Ability to understand and follow oral and written directions.
- Ability to work independently or in a team situation.
- Ability to communicate and effectively interact with co-workers, supervisors, and the general public sufficient to exchange or convey information and to give and receive work direction.
MENTAL & COGNITIVE DEMANDS:
- Must be able to read, analyze, and interpret technical data; provide response in a timely and professional manner; able to write procedures and policies; able to communicate clearly and succinctly on a technical level.
- Must be able to document issues and resulting resolutions.
- Must be able to solve problems.
- Ability to solve practical problems; ability to interpret and understand a variety of instructions furnished in written, oral, diagram or schedule form.
- Must be able to lift up to 30 lbs.
- Ability to verbally communicate with, hear and understand others.
- Ability to sit and/or stand for extended periods of time.
- Ability to walk, reach with hands and arms.
- Ability to perform repetitive movements of the fingers, hands, wrists and arms.
OTHER DUTIES AND RESPONSIBILITIES (INCLUDE):
KNOWLEDGE AND EXPERIENCE:
Minimum of seven (7) years of experience in a laboratory quality-related field.
Minimum of four (4) years environmental/radiochemistry laboratory experience.
Expert knowledge of quality assurance concepts and principles.
Expert knowledge of ARS-001 QA Assurance plans and implementation.
Expert Knowledge of Luckey project requirements, specifications, functional interfaces with client and laboratory staff.
Demonstrated knowledge of performing internal quality assessments, QSM 5.1 requirements, as it applies to project requirements, surveillances, etc.
Demonstrated knowledge of LOD/LOQ requirements, verifications, control chart maintenance and trending.
Demonstrated knowledge of sample, contact and data management functional implementation.
- Valid state driver’s license.
- Ability to pass a pre-employment background check.
- Ability to pass pre-employment and random drug screens.
- Must occasionally be available for additional work hours outside of the normal work schedule including holidays and weekends.
- Must be able to travel as required.
Certified Quality Auditor (CQA); Certified Manager of Quality/Organizational Excellence (CQM/OE); NQA-1 Certified Lead Auditor
Minimum of seven (7) to ten (10) years in laboratory quality; minimum of five (5) to seven (7) years experience in a management/supervisory position. Ability to obtain professional certification in quality obtained through the American Society for Quality.