Quality Control Technician

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 a hourly, full time and onsite 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 21

CFR
820- QSR)

• Technical experience relating to testing of medical devices.

• Englisch 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

Physical Requirements and Work Conditions

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Mobility & Posture:
  May require occasional sitting, standing, walking, climbing,…