
Manufacturing Process Specialist
hace 11 horas
Qrc Group Llc seeks a Manufacturing Process Specialist to lead and support aseptic manufacturing processes at designated locations.
The ideal candidate will have a strong background in aseptic pharmaceutical manufacturing and quality environments.
Main Responsibilities:
Technical support of formulation, aseptic filling and sealing operations.
Aseptic process simulations.
Project tracking and completion.
Collaboration with cross-functional teams to deliver key milestones for projects.
Requirements:
Bachelor's Degree in a technical field is required.
Minimum 5 years of experience in aseptic pharmaceutical manufacturing and/or quality environment is required.
Thorough knowledge of GMPs and understanding in aseptic processing is required.
Bilingual (Spanish/English) is preferred.
Must be self-directed and requires an appropriate level of education and experience to make and act upon decisions that impact the site from an aseptic standpoint.
Working knowledge of 21CFR part 211 FDA regulations is required.
Knowledge of various quality and root cause analysis tools is preferred.
Prior investigation writing experience with determination of product impact is preferred.
MS Office skills are essential.
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