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Sr Quality Engineer
4 months ago
Responsibilities:
Identifying risk, developing complex mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups such as Manufacturing, Quality Control, IT, Engineering and Validation.
Supporting the oversight of Data Integrity and Computer System Validation efforts, system lifecycle and improvements.
Supporting cGMP quality improvement efforts at iCTC (Philadelphia, PA) and in remote facilities such as IOVA-A (Philadelphia, PA) and the Tampa Labs (Tampa Bay, FL).
Creating and maintaining company documentation, such as quality manuals, and quality procedures.
Applying good manufacturing practice and observing that it is being adhered to.
Represent Quality on cross-functional teams to complete projects, address quality issues and implement quality system improvements.
Provide technical guidance to cross-functional teams on quality engineering activities that integrate into multiple product lines and/or systems with significant complexity including root cause analysis investigations, addressing purchased component quality issues, complaint product evaluations, development and implementation of corrective actions, initiation and approval of product/process changes and disposition of discrepant material.
Requirements:
5+ years of biopharmaceutical industry experience in a technical or supporting technical role
BA/BS degree in scientific or engineering discipline
3+ years leading or supporting GxP Computer System implementation and validation
Demonstrable experience creating and utilizing inspection/testing systems.
Strong experience developing and executing protocols for single-use process systems, lab systems and software applications in a cGMP environment
Demonstrable experience creating and maintaining policies, processes and procedures for a new cGMP facility
Demonstrable experience utilizing risk-based assessments and setting up lifecycle verification programs for manufacturing and laboratory systems.
Ability to effectively communicate with management and project team members
Experience in preparing for and participating in regulatory inspections to ensure successful outcomes
Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results
Strong professional interpersonal and communications skills, both verbal and written to provide clear direction for the business, vendors, internal stakeholders.
Ability to meet deadlines and multi-task efficiently.
Must be comfortable in a fast-paced environment with minimal direction and changing priorities.
Experience identifying changes, driving improvements, and streamlining processes required.
Proficient with the Microsoft Office Suite, Word, Excel, PowerPoint, and Project.