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Quality Systems Director - Charleston, United States - GEL Engineering, LLC
3 weeks ago
Description
One of the largest single-site production laboratories in the countryState-of-the-art instrumentation and technology
Career-based employment
Over 40 years of experience in laboratory operations
GEL Laboratories, LLC
, an affiliate of The GEL Group, Inc.,
provides comprehensive chemistry and radiochemistry analytical services for a full range of complex and demanding requirements, including testing for some of the largest government institutions, and nuclear power and industrial companies in the US and abroad.
We combine the most advanced technology, the proven experience of our laboratory personnel and a commitment to always delivering defensible data on time.
GEL's core purpose is to improve the quality of life of this and future generations by helping people protect and be good stewards of our environment and natural resources.
Summary:
The Quality Systems Director (QSD) is responsible for management and direction of the Quality Group and Quality Systems for the laboratory operations.
The QSD maintains the overall compliance of the laboratory operations with GEL's Quality Assurance (QA) program and ensures that quality objectives established by management, regulatory programs and project plans are always followed.
The QSD has the final authority to accept or reject data, and to stop work in progress in the event that procedures or practices compromise the validity and integrity of analytical data.
The QSD is available to any employee to resolve data quality or ethical issues.In addition, this position is responsible for the following:
Responsibilities include, but are not limited to, the following:
Establishing, documenting, and maintaining comprehensive and effective quality systems.
Developing and evaluating quality assurance policies and procedures pertinent to our laboratory functions and communicating these with the division directors and managers.
Ensuring that the operations of the lab are in conformance with the Quality Assurance Plan and meet the quality requirements specific to each analytical method.
Ensuring that laboratory activities are incompliance with local, state, and federal environmental laws and regulations.Reviewing project-specific quality assurance plans.
Ensuring that quality control limits are established and followed for critical points in all measurement processes.
Administering internal and external performance evaluation studies using commercially purchased certified, high-purity standard reference materials.
Performing independent quality reviews of randomly selected data reports.
Conducting periodic audits to ensure method compliance.
Conducting or arranging periodic technical system evaluations of facilities, instruments, and operations.
Overseeing and monitoring the progress of nonconformance's and corrective actions.
Communicating system deficiencies, recommending corrective action to improve the system, and defining the validity of data generated during out-of-control situations.
Preparing and updating quality assurance documents and reports to management.Coordinating inter-laboratory reviews and comparison studies.
Overseeing Stop Work Orders in out-of-control situations.
Administering accreditation and licensing.
Administering the document control system.
Providing guidance and training to laboratory staff as requested.
Providing procedures to ensure confidential reporting of ethical issues or concerns.
Evaluating subcontractors and vendors that provide analytical and calibration services.
Designating quality systems authorities in times of absence to one or more appropriately knowledgeable individuals.
Overseeing notification if required for compliance with Energy Reorganization Act, 1974, 10 CFR, Part 21, should data recall be necessary.
Ensuring that the laboratory has policies to avoid involvement in activities or relationships which might negatively affect confidence in the laboratory's competence, impartiality, judgement or operational integrity.
Ensuring that management and personnel are free from undue internal and external pressures and influences that may adversely affect their impartiality, affecting the quality of their work, by mitigating pressures.
Ensuring that employee competence measurements are established and monitored.Establishing, maintaining, and training to the documented data integrity system.
Typical Education and Experience Required:
Bachelor's degree in chemistry, biology, or a closely related field
15 + years of experience in the environmental laboratory industry which includes direct experience in the management of quality systems
Knowledge Requirements:
Demonstrated working knowledge of DOE / DOD QSM, NELAP, ISO17025:2017, TNI Standards, DOELAP, NUPIC and state regulatory environmental laboratory programs.
Work with laboratory personnel, regulators, and clients to solve issues/problems.
Comprehensive principles, practices and techniques of quality systems and operational areas.
Understanding of the development and implementation of quality programs, policies and procedures.
Applicable quality laws, codes and regulations.
Interpreting, applying and explaining applicable laws, codes and regulations.
Advanced oral and written communications skills.
Strong self-initiative and resource utilization.
Advanced Mathematical and reasoning skills.
Solid critical thinking skills to anticipate and solve problems in a systematic manner.
Advanced proficiency in Microsoft Office (Word, Excel, Outlook).
Other Knowledge and Skill Requirements:
Demonstrates and supports company core values.
Demonstrates analytical/advanced math and computer skills.
Exhibits organizational skills and attention to detail.
Possesses strong verbal and written communication skills.
What We Offer:
Commitment to safety
Corporate values that promote respect, integrity, and innovation
Competitive compensation
Medical, dental and vision insurance coverage
Life Insurance Plans, including Accidental and Critical Illness plans
Company-paid short and long-term disability insurance
401k plan with employer matching
Gym membership reimbursement
Paid Time Off and holiday leave
Physical Requirements and Working Environment:
The physical demands outlined are representative of those that must be met by an employee to successfully perform the essential functions of the job.
Work is performed in a laboratory/warehouse setting which is subject to chemicals, and potential fumes, gasses, noxious odors and related items typical for this environment.
Safety equipment is provided as applicable, and use is mandatory.General Comments
This Position Description is intended to provide a general guideline of the requirements, duties, and responsibilities for this position.
It is not intended to be an all-inclusive description of the position, nor is it intended to place limitations on the position.
As with all positions in the company, the successful employee will constantly look for ways to contribute to the well-being of the company, and thereby to their own well-being and success in their own professional career.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, disability, or status as a protected veteran.
Accessibility:
If you need an accommodation as part of the employment process please contact Human Resources at
Phone:
Email:
Equal Opportunity Employer, including disabled and veterans.
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