Are you the right scientist to work in a fast-paced manufacturing environment with cross-functional focus? Would you enjoy working on a team developing one culture based on trust, accountability, ownership, and world class performance? We are looking for a candidate to join our Quality Control team who will be involved in supporting a newly established reagent manufacturing system within an Immunoassay product line. Come join our team and embrace the Siemens belief of “Know now, live better…”
This position is a Quality Control function in which the Scientist will work with a team of scientists to ensure timely release of intermediate and finished good products. Assurance of compliance with all regulatory standards and regulations as well as compliance with all corporate policies and guidelines is required.
Major Job Responsibilities
- Performs a wide variety of assignments according to established procedures, including but not limited routine and moderate tests/analyses, data review and analysis, as well as panel preparations
- Completes preparation of product release reports
- Reviews documentation generated by the lab prior to release to ensure accuracy and completeness
- Provides inputs used for the purpose of control charting and trending of data collected through the release process
- Ensures compliance of current procedures and processes and as needed reviews and updates documentation
- Communicates issues encountered in the lab to initiate the investigation phase as well as aids in troubleshooting process with the lab supervisor
- Participation in validation activities for equipment qualifications and process implementations
- Completes audit of lab instrumentation
Required Knowledge/Skills, Education, and Experience
- B.A. or B.S. Degree in biology, chemistry or another science related field.
- Typically 1-2 years of successful experience in quality processes and knowledge of quality related processes and systems
- Well-developed written and verbal communication skills
- Solid interpersonal and collaboration skills
- Proficient in Windows-based applications
- Experience working with analytical instrumentation, reagent systems, including testing repetitively.
- Experience performing data analysis and some familiarity with statistical analysis tools.
- Should be comfortable with handling bio-hazardous materials.
- Thorough understanding of 21 CFR Part 820 regulations and ISO 13485 standard requirements, and all other MDSAP country regulations for medical device or pharmaceutical operations.
Preferred but not Required
- Experience with immunoassay-based technologies.
- Familiar with working in SAP.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Early Professional
Job Type: Full-time
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