Quality Engineer
Philadelphia, PA, United States
Red Lion Road-PA002
Position Title: Quality Engineer
Location: Philadelphia, PA - Red Lion Road
Department: Quality -- Validations
Shift: 1st
Reporting To: Director of Validation
Responsible For (Staff): no
The Quality Engineer has the primary function of supporting the technical aspects on the onboarding of new clients, products, and processes to the Philadelphia site. The role involves utilizing technical expertise, excellent communication, and project management skills in interacting and collaborating with internal team members, customers, suppliers, and contract service providers. The position will be responsible for driving timeline commitments for new projects. The Quality Engineer will also function as a technical resource in deviations, defect analysis, complaints, establishing sampling plans, assessments, and protocols.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Capable of resolving complex issues through collaboration with internal and external parties* Participate in External Audits of Suppliers/Contract Service Providers* Manage activities and timelines associated with supporting onboarding new business* Excellent technical writing skills* Development and/or review of technical specifications* Test method transfer or method validation activities* Development of sampling plans for OQ/PQ activities (includes Serialization and Sterilization activities)* Supports the generation of documentation such as Control Plans, Process Flow Maps, Inspection plans and techniques, GR&R & test requirements.* Facilitating/Participating in FMEA Risk Assessments related to products and processes* Statistical data analysis* Trend manufacturing data and contract service providers results* Development of validation/re-qualification protocols* Assist in the development of Master Batch Records* Act as technical resource for onboarding new equipment* Technical resource in meetings/calls with customers* Assist in root cause analysis of deviations/complaints* Participate in Customer and Regulatory Audits as needed* Knowledge of and adherence to all PCI, cGMP and GCP policies, procedures, and rules* This position may require extra hours and/or weekend work.* Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.* Attendance to work is an essential function of this position* Performs other duties as assigned by Manager/Supervisor.
Special Demands:
* Stationary Position: From 1/4 to 1/2 of the day.* Move, Traverse: From 1/4 to 1/2 of the day.* Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day.* Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day.* Ascend/Descend or Work Atop: Up to 1/4 of the day.* Position self (to) or Move (about or to): Up to 1/4 of the day.* Communicate or exchange information: 3/4 of the day and up.* Detect, distinguish, or determine: 3/4 of the day and up.
On an average day, the individual can expect to move and/or transport up to 10 pounds
less than 1/4 of the day.
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