Quality Engineer – QC Labs (19-00744) – TX – Fort Worth

Duties: Provides mentoring, assistance, support and oversight to Quality Control Laboratories related to validation and qualification change control, calibration, preventive maintenance, root cause investigations and investigation tools, corrective and preventive actions, general process challenges and troubleshooting, as well as execution of risk management processes (risk identification, mitigation, and controls) in compliance with external standards and corporate requirements.

Provide direction and quality oversight in the development, maintenance, and compliance of Quality Systems directly related to Quality Control Laboratory operations.
Lead the quality oversight of larger-scope and more technically complex non-conformance investigations and implementation of corrective and preventive actions.
Perform evaluations of process quality and performance attributes to identify continuous improvement initiatives related to Quality Systems and process control infrastructure to ensure continued sustainability of manufacturing operations and products.
Actively participate in and contribute to routine engineering and manufacturing-based meetings, including presentation of metrics, process challenges, Quality-related initiatives, etc.
Provide a source of consistent quality oversite to engineering lifecycle and change control. This includes; proper matrixed validation approach, attribute inspections, exception handling, proper order of operations, timely closure, appropriate validation paths, reviews of holistic validation packages.
PPC (Product or Process Change)
URS/FRS (User Requirement Specification/Functional Requirement Specification)
SDD (Software Design Document)
ECO (Engineering Change Order)
FAT (Factory Acceptance Test)
Project VMPs (Validation Master Plan)
TMD (Traceability Matrix)
IOQ (Installation Operation Qualification)
PQ (Performance Qualification)

Ensure consistent application of GDP and DI on all documentation.
Provides Quality representation and approvals at the Change Control Board for change requests within respective product areas.
Participate in efforts to streamline change control and Automation Lifecycle Management processes.
Initiate Engineering Change Control (ECO) and Product Process Change (PPC) documentation
Assure adequate product and process controls are in place for identified CTQs. Uses various statistical and non-statistical problem-solving tools as part of analysis.

Skills: Minimum Education / Experience:

Bachelor’s Degree in a scientific technical discipline (preferably engineering, chemistry or microbiology) 5+ years combined experience in pharmaceutical, Medical Device or Biotechnology Industries, including experience with investigations, root cause analysis, CAPA, computerized system knowledge, product and process validation, trending, and change control
Microsoft Office Suite with advanced Excel charting experience and statistical analysis capability
Proven problem solving skills, and ability to meet deadlines under pressure
Well organized, with good time-management skills, ability to build rapport

Desired Experience:

Technical understanding of aseptic process or QC laboratory process
Quality Lab Experience
Strong GMP Documentation Skills
Above average understanding of Manufacturing / Production Principles
Strong computer skills, including Microsoft Word, Excel, Power Point, and Project
Excellent organizational skills

Ability to manage multiple priorities
Previous experience with FT-IR, HIAC, microscopic examination, LIMS and track wise preferred.

Keywords:
Education:
Bachelor’s Degree in a scientific technical discipline (preferably engineering, chemistry or microbiology) 5+ years combined experience in pharmaceutical, Medical Device or Biotechnology Industries, including experience with investigations, root cause analysis, CAPA, computerized system knowledge, product and process validation, trending, and change control

Source: Job Diva – Job Listing

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