Associate Quality Assurance Microbiologist
29. Jan 2019
Andover - USA
Fachleute (erfahren, Spezialisten)
Straumann partners with passionate people who fit in with the agile dynamics of our size-for-success company. People at Straumann appreciate the opportunity to shape the future and create impact. Encouraging leadership and inspiring ideas from our people have guided us through our proud history of pioneering innovations.
- Process owner for environmental, process, and product monitoring; this includes biological tests, particle counts, elemental surface analysis, chemical tests, purified water tests, and product sterility testing. Responsible to define requirements, perform tests, review results with management, and re-assess requirements.
- Manage and coordinate all monitoring and test results. Ensure weekly microbiological product processing requirements are met. Provide complete, accurate, well organized documentation to maintain quality system compliance.
- Lead failure investigation of product, process, and environmental excursions by root cause investigation, microorganism identification, testing, and documenting results.
- Perform quality assurance laboratory testing as required to support SLA / SLActive production; this includes surface topography, hydrophilicity testing, and product vial testing
- Review cleaning practices and lead cleaning validations when required
- Train employees in Cleanroom practices.
- Perform Sterility Adoption assessments as required
- Periodically assess PFMEA and validation status for sterility, PWS, and cleanrooms
- Obtain Bioburden Recovery Factors (BRF’s) as required
- Participate in incoming inspection of purchased materials as required
- Provide monthly metrics summarizing lab performance and product, process, and environmental monitoring results
- Identify areas for improvement; recommend and implement solutions
- Responsible for answering audit questions regarding microbiological compliance.
- Maintain job related processes / work instructions
- Support NCMR’s, ECO’s, CAPA’s, etc.as required
- Participate in meeting departmental goals and objectives
- Other duties as may be assigned by the Head of Quality Management
The individual filling this position will provide support to Quality and Manufacturing in areas of quality assurance related to microbiology. Provide hands on participation, assistance, and leadership in activities such as environmental and product monitoring, excursion failure investigation, microorganism identification, cleaning validations, and other duties as assigned by the Head of Quality Management.
- Minimum Qualifications:
- Familiar with Good Lab Practices (GLP)
- Strict, uncompromising adherence to quality standards
- Effective verbal and written communication skills
- Analytical problem solving skills
- Organized and detail oriented
- Word, Excel, and statistical software computer skills
- General office environment; no special physical demands required
• Associates degree in biology /related field or Higher
• 1 to 3 years’ experience in a quality assurance lab environment
Required Knowledge and Skills:
Work Environment and Physical Demands: