Quality Engineer

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Quality Engineer

Exton, Pennsylvania

|

Direct (Permanent) Full Time

|

$ 120,000 - $ 150,000 per year

Exton, Pennsylvania

Direct (Permanent) Full Time

$ 120,000 - $ 150,000 per year

January 23, 2023

|

Job ID: T1313454SAN_1674516538

January 23, 2023

Job ID: T1313454SAN_1674516538

Job Summary

Job Id: T1313454SAN_1674516538 Apply Now

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.
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.
T1313454SAN_1674516538

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About Beacon Hill

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

We look forward to working with you.

Beacon Hill. Employing the Future™