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Quality Assurance Senior Specialist- 1st Shift- Environment Testing

23 days ago
Full time role
In-person 路 Lancaster, PA, US... more

The Quality Assurance Senior Specialist is responsible for ensuring quality of operations and data being produced in the laboratories; ensuring laboratory adherence to government regulations and client requirements; independently performing complex work and special projects in addition to routine and non-routine duties.

Essential Duties and Responsibilities:

  • Applies GMP/GLP in all areas of responsibility, as appropriate
  • Demonstrates and promotes the company vision
  • Regular attendance and punctuality
  • Apply other applicable regulations based on assignment, such as EPA, NELAC, State programs, PALA, and A2LA
  • Review client or agency documents and identify requirements outside our usual practices, communicate to technical operations, assist with implementing appropriate changes
  • Keep abreast of regulatory or industry quality assurance (QA) requirements, consult with clients or regulatory authorities regarding any special QA requirements they may have, assist technical operations with application and interpretation
  • Assist and/or prepare and present departmental and corporate training programs as needed to satisfy regulatory requirements
  • Provide information and revision support for updating company publications including quality policy manuals, company web site, and newsletters
  • Identify and drive system improvements, both within the department and for laboratory operations; determine the most effective way to accomplish a goal or strategy; suggest improvements to maximize quality and productivity
  • Demonstrate skill in using the computer to access information, perform job functions (e.g., spreadsheets, power point), and prepare other reports
  • Perform data review (analytical, validation, investigations), review for compliance and identify issues, provide options for resolution
  • Review QC data and nonconformance issues for assigned technical groups, evaluate for trends or patterns
  • Investigate and document QA, method, and regulatory deficiencies within the lab; take investigation to next level when needed; diagnose and solve problems independently
  • Implement and document computer program changes, review computer system documents, provide feedback to meet regulatory and industry expectations
  • Perform internal laboratory audits (traceability, observation, and comprehensive), share best practices, offer compliance options, keep management informed of issues
  • Perform other duties as assigned 

Position is full time, 1st shift. M-F 9am-5pm, with additional hours as needed 

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