Lab QA Manager

2 weeks ago

Knoxville, United States Teledyne Brown Engineering Full time

Job Summary:

Provides support to production areas for quality issues and questions. May participates in external, internal and supplier audits. Maintains documentation on audit findings and is responsible for following up on corrective action plans and areas of nonconformance. At this level, tasks and assignments tend to be general but may involve complex and/or non-routine assignments and duties are performed under limited supervision.


Essential Duties and Responsibilities performed under limited supervision include the following. Other duties may be assigned.


  • Primary responsibilities are to analyze and enhance overall quality management system practices.


  • Supports/facilitates process improvement in areas such as supplier assessment, contractual and regulatory compliance, and product manufacture.


  • Participates in performing compliance audits to verify adherence to company policies, standards, and procedures.


  • Performs queries of established databases to derive trend analysis data and provides feedback in support of product and system improvements to enhance the effectiveness of the quality system.


  • Prepares written reports of findings obtained from analysis, including the results of internal audits.


  • Prepares business reports, feasibility studies, and justification statements when a requirement.


  • Participates in the Quality Planning process as focused in identifying, and ensuring satisfaction of customer order requirements.


  • Participates in the customer satisfaction assessment process.


  • May assist in the generation of SOP's, GMP's, and Quality System procedures or changes thereto when required.


  • Assists in preparation for Teledyne's annual ISO 9001 recertification audit.


  • Uses SPC principles in support of root cause analysis when assessing production anomalies, including variability studies.


  • May perform product/process inspections if specifically trained.


  • Supports maintenance of the company's training and records retention programs


  • Daily availability to include evenings and weekends when necessary to reach goals and deadlines.


Position Specific Summary and Responsibilities

  • Establishes, documents, and maintains an effective quality assurance program that is in compliance with client contract and regulatory compliance.


  • Reviews, maintains and updates quality requirements for procedures, the Quality Manual and supplemental documentation.


  • Reviews proposals, contracts, and purchase orders, if applicable, to determine that adequate quality control procedures and programs are in place to meet client and regulatory quality requirements.


  • Initiates preparation, review, approval and publishing of procedures based upon an established schedule.


  • Trains staff to quality procedures and maintains DOC and training records.


  • Approves and/or sets criteria for lab equipment and internal quality control.


  • Reviews and evaluates intralaboratory QC data (blanks, spikes, duplicates, matrix spikes/dups).


  • Ensures the interlaboratory performance evaluation program is representative of client sample analyses and matrices, where available, evaluating the results, and initiating corrective actions for any unacceptable results.


  • Conducts or arranges for periodic internal audits and management reviews, as well as coordinating external audits.


  • Tracks and verifies non-conformances from initiation through closure, including root cause analysis and reviewing or generating planned corrective actions. Determines the effectiveness of corrective actions.


  • Qualifies and maintains an approved supplier list for purchasing lab standards, proficiency testing, calibrations, and lab subcontractors.


  • Coordinates and maintains accreditations and licensing.


  • Notifies management of deficiencies in the quality system.


  • Produces an annual management report to the Operations Manager, Director of Quality and other management personnel (as applicable) that summarizes the status and effectiveness of the QA program.


  • Approves raw data and reviews client reports as needed.


  • Assists Project Management with preparation & generation of annual REMP reports as needed.


  • Delegates a qualified authority due to extended absence.


  • Assists with Emergency Response duties and planning.


Supervisory Responsibilities

This job has no supervisory responsibilities but may include providing technical leadership to lower-level Analysts.


Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


Education and/or Experience:

Bachelor’s degree in chemistry, environmental, biological, physical sciences or engineering including 24 semester hours of chemistry and 5 or more years of laboratory experience (one year of directly related), or equivalent combination of education, training and experience. Course level or hands-on QA/QC experience preferred.


Position may require one or more of the following (Site/CBU Specific):


Other Essential Duties:

  • Follows all import/export requirements, consulting with facility import/export personnel as required.


Other Skills and Abilities:

  • Detailed Knowledge of ISO 17025
  • Ability to work without direct supervision and use initiative and independent judgment to accomplish quality directives.
  • Understanding of the administration & oversight of quality programs, policies and procedures
  • Ability to research and understand regulatory requirements and effectively incorporate any needed changes into the lab’s quality system.
  • Excellent interpersonal, communication and problem-solving skills for quality issues
  • Ability to use Microsoft Office applications and the Laboratory Information Management System (LIMS)


Other Qualifications:

  • Ability to travel (domestically/internationally) approximately +/-10%.
  • US Citizenship with ability to attain/maintain government security clearance.

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