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Quality Assurance Analyst
hace 3 meses
Company Overview: Lonza is a leading global entity in the life sciences sector, operating across multiple continents. Our success is driven by the collaborative efforts of talented individuals who generate innovative ideas that assist businesses in enhancing lives. We empower our employees to take charge of their careers, fostering an environment where their contributions, both significant and minor, can lead to meaningful improvements in the world.
Position Summary: The Quality Control Specialist serves as a key expert in specific areas within the quality control domain. This role acts as a primary representative for the QC department, facilitating communication between the QC Laboratory and both internal and external stakeholders. The individual will tackle moderately complex assignments that require substantial judgment and initiative to resolve issues and provide recommendations. Furthermore, this role involves analyzing situations or data that necessitate a thorough evaluation of various factors.
Key Responsibilities:
- Act as the Quality Control representative in various internal and customer project teams.
- Monitor QC testing, manage project commitments, follow up on action items, coordinate analytical discussions, and assist in problem resolution.
- Compile and present product data to internal and external stakeholders, driving necessary process changes and managing deviations.
- Independently lead projects to ensure timely completion.
- Initiate and finalize required process change controls, deviations, and laboratory investigation reports.
- Oversee technology transfers and method validations within the laboratory settings.
- Determine methods and procedures for new assignments independently, while providing guidance to other QC personnel as needed.
- Ensure readiness for regulatory and customer inspections, representing the department during audits.
- Provide backup supervision when necessary.
- Engage in non-routine assignments, problem-solving, and project management.
- Perform additional duties as assigned.
Key Requirements:
- Preferred educational background includes an Associate's or Bachelor's degree in a science-related field, or equivalent industry experience in Quality Control.
- Knowledge of Good Manufacturing Practices (GMP) is essential.
- A minimum of 2 years of relevant quality experience is required.
- Proficient communication skills in English are necessary.
- Prior laboratory experience is preferred.
- Experience in protocol writing is advantageous.
- Familiarity with report writing, documentation control, and Standard Operating Procedure (SOP) review is preferred.
- Experience with Laboratory Information Management Systems (LIMS), Trackwise, and Empower is beneficial.
At Lonza, we recognize that our products and services positively impact millions of lives. This responsibility drives our commitment to ethical practices in achieving our business objectives. We value the challenge and creativity involved in addressing complex problems and innovating within the life sciences field, offering our employees the fulfillment that comes from making a significant difference in the world.
