Beacon Hill Staffing Group
Quality Engineer
Exton, Pennsylvania
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Job Id: T1313454SAN_1674516538
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Key Responsibilities:
* Tracks, trends, and reports on key quality performance indicators (KPIs), including non-
conforming products, complaints, CAPAs, and process controls.
* Lead and execute risk assessments, gap assessments, FMEA, root cause analysis, and
continuous improvement plans to ensure product quality and regulatory compliance.
* Write and/or review technical non-conformance and deviation reports for facilities,
utilities, equipment, processes, and computer systems.
* Provide technical input for operational control and validation strategies and effectively
communicate strategies to internal and external stakeholders.
utilities, equipment, processes, and computer systems.
* Provide technical input for operational control and validation strategies and effectively
communicate strategies to internal and external stakeholders.
Additional responsibilities include:
o Development of project design documentation.
o Generating validation plans for larger projects.
o Compilation of validation protocols and reports.
o Collation and analysis of process validation data.
o Witnessing of certain validation activities.
o Regularly update the schedule of current validation projects.
* Schedule and manage the qualification of new equipment and periodic re-
evaluation/requalification of existing equipment and systems, per Castle Creek
procedures and policy.
* Collaborate with Maintenance regarding maintenance routines.
* Collaborate with Metrology on calibration tolerance and frequency.
* Act as a quality SME during change control planning and execution for projects which
require input of a technical operational control nature.
* Provide software quality and validation leadership and be the SME for GXP
computerized systems. Apply risk-based methodology to validation/qualification efforts
in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5.
* Interprets regulatory requirements for electronic and data integrity systems to identify,
support and/or manage process improvement initiatives to ensure compliance with GxP
regulatory requirements and Electronic Records/Electronic Signatures regulations.
Participates in inspection readiness for regulatory inspections.
* Oversee and execute software quality and validation strategy in support of custom
software systems, COTS configuration, workflow, and/or analytics to improve the overall
accuracy, efficiency, and effectiveness of electronic computerized systems.
* Evaluate and recommend quality process changes by keeping abreast of the
requirements for compliance.
* Participate and support the external audit program for vendors related to GXP
computerized systems, equipment, and processes.
* Effectively identify and resolve complex system issues and appropriately communicate
gating items to senior management and stakeholders.
Computer Skills:
* Basic competency in use of PowerPoint, Microsoft Word, Excel, database management
and statistical analysis.
* Proficient in 21 CFR Part 11 compliance requirements.
o Development of project design documentation.
o Generating validation plans for larger projects.
o Compilation of validation protocols and reports.
o Collation and analysis of process validation data.
o Witnessing of certain validation activities.
o Regularly update the schedule of current validation projects.
* Schedule and manage the qualification of new equipment and periodic re-
evaluation/requalification of existing equipment and systems, per Castle Creek
procedures and policy.
* Collaborate with Maintenance regarding maintenance routines.
* Collaborate with Metrology on calibration tolerance and frequency.
* Act as a quality SME during change control planning and execution for projects which
require input of a technical operational control nature.
* Provide software quality and validation leadership and be the SME for GXP
computerized systems. Apply risk-based methodology to validation/qualification efforts
in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5.
* Interprets regulatory requirements for electronic and data integrity systems to identify,
support and/or manage process improvement initiatives to ensure compliance with GxP
regulatory requirements and Electronic Records/Electronic Signatures regulations.
Participates in inspection readiness for regulatory inspections.
* Oversee and execute software quality and validation strategy in support of custom
software systems, COTS configuration, workflow, and/or analytics to improve the overall
accuracy, efficiency, and effectiveness of electronic computerized systems.
* Evaluate and recommend quality process changes by keeping abreast of the
requirements for compliance.
* Participate and support the external audit program for vendors related to GXP
computerized systems, equipment, and processes.
* Effectively identify and resolve complex system issues and appropriately communicate
gating items to senior management and stakeholders.
Computer Skills:
* Basic competency in use of PowerPoint, Microsoft Word, Excel, database management
and statistical analysis.
* Proficient in 21 CFR Part 11 compliance requirements.
T1313454SAN_1674516538