Overview:
Responsible for planning/coordinating testing and inspection activities related to company products, and recording, analyzing and approving results during product development and manufacturing. Also responsible for environmental monitoring activities.
Responsibilities include, but are not limited to:
Coordination and planning of internal and external QC testing
Performance and reporting of inspection and testing of raw materials, production related materials and company products (intermediate and finished products)
Sampling of (raw) materials and products for inspection & testing
Release of raw materials and production related materials
Coordination, planning, performance and reporting of environmental monitoring (EM) of production areas and utilities
Coordination, planning and testing of samples relating to shelf life and validation studies
Calibration and maintenance of QC and EM related equipment, and maintenance of QC laboratory/areas
This is an hourly, full-time and on-site position. The hourly rate for this position is $20-$24.57 an hour.
Key Responsibilities:
Technical
Sampling of incoming (raw) materials, (final) products, shelf-life and validation samples
Plan, perform and report inspection & routine testing of incoming materials and products
Release of incoming (raw) materials
Plan, perform and report testing in relation to shelf-life and validation studies
Communication with external test laboratories with regard to planning, execution and reporting of testing
Shipment of samples to external test laboratories
Inspection activities relating to product labelling
Implement and maintain QC databases, in order to ensure that relevant information is up to date and accessible to relevant functions.
Initiate and/or review Quality Indicators (Qis), including, but not limited to, deviations and out of specification reports, as necessary, in relation to QC activities
Coordinates, plans and performs equipment calibration and maintenance activities with regard to equipment for QC and EM purposes
Participate in product development and risk management teams, when required, in relation to QC and EM related topics
Training of any existing and new QC personnel, as required
Coordination and planning of Quarterly Dose Audits (QDA)
Maintenance of equipment files
QA/QC Regulatory
Write and/or review or approve quality control procedures and related documentation, including but not limited to specification documents and testing procedures
Knowledge of relevant quality control requirements. Keep up-to-date on QC related topics and share information with colleagues.
Suggest possible improvements to current testing and identify needs for changes in the Quality Management System.
Safety/Organizational/Productivity
Know, understand and adhere to all safety standards, i.e., emergency preparedness, chemical, infectious agents and radioactive hazards.
Participate in the introduction and evaluation of new procedures, supplies and equipment to the extent necessary for proper and safe performance of work activities.
Ensure proper training of colleagues, students, etc. as necessary
Use resources (equipment, disposables, time) in a responsible, cost-effective manner.
Qualifications
Bachelor Biomedical, Biotechnology, Laboratory
Experience with relevant Quality systems and regulatory requirements ISO 13485 / ISO 9001 / cGMP (FDA 21CFR820- QSR)
Technical experience relating to testing of medical devices.
English language on C-Level
Skills
Able to work independently, hands on mentality.
Accurate and pro-active.
Good interpersonal and communication skills are necessary.
Team player, able to work cooperatively in a professional team.
Travel Requirement:
Ability to travel domestic and international if applicable