Quality Management Assistant
· Assist and support QA/QC Manager in the organization of the quality department for planning, meetings (in absence of QA/QC Manager), evaluations, and special projects.
· Assist QA/QC Manager create, revise, implement and train quality procedures and policies.
· Support the QA/QC Quality Management System, including: QC, Validations, CAPAs, and special projects.
· Communication with Austrian and German QA departments in regards to projects and evaluation of non conformities.
· Perform and help organize quality related trainings for QM system in department and for the whole organization.
· Lead evaluation and investigation on certain nonconformances with local QC Manager.
· Assist in organizing Quality Irregularity Reports, perform reporting (monthly, quarterly, key figures, etc.) and trend analysis.
· Analyze processes and reports for continuous improvements possibilities and lead resulting projects.
· Lead special projects in planning and implementation.
· Coordinate SAP processes for all QA/QC departments and issue procedures.
· Organize and maintain the Document Control Room.
· Other duties as assigned.
· Issue and revise QM documents. Sign operational QM documents after information of QA/QC Manager and in absence of QA/QC Manager.
· Communication with GBO Austria and GBO Frickenhausen in regards to special projects, corrections and improvements.
· Evaluate and finalize complaints as substitute of QC Manager or QA/QC Manager.
· Minimum Bachelor’s Degree in STEM or related field.
· At least 2 years of relevant work experience in laboratory environment.
· Experience in Medical Device, Pharmaceutical, and/or regulated industry.
· Proficient computer skills in MS office
· Must have strong communication and writing skills
· Must have strong mathematical and science calculation skills.
· Must have SAP experience.
· Must be able to sit for up to 8 hours.
· Must have appropriate vision to perform detailed quality inspections as outlined in SOPs and TPs.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, sex, sexual orientation, gender identity, genetic information, age national origin, veteran status, physical or mental disability or any other characteristics protected under applicable federal, state or local law.
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