QC Analyst Level 1

at  Bimeda

Reporting to the Quality Control Supervisor, the QC Analyst I is responsible for sampling and analyzing environmental monitoring samples, conducting tests on water samples, raw materials, finished products, stability samples, and validation samples. The role requires supporting various aspects of QC Lab operations, including organization, application of 5S principles for all lab activities, material receipt, equipment calibration, and solution preparation.

SKILLS/ KNOWLEDGE/BEHAVIOURS:

• Organize: Manage samples, data, projects, and equipment efficiently.
• Collaborative: Being able to work effectively with others is crucial for the success of projects and experiments. This also includes taking initiative to learn new techniques, improve processes, or suggest innovations can set a lab analyst apart.
• Clear and concise communication is essential for conveying findings, collaborating with team members, and writing GMP documentation.
• Prioritisation skills and the ability to work autonomously.

KEY ROLE SPECIFIC REQUIREMENTS:

• Conduct sampling for Environmental Monitoring in adherence to procedures, GLP, and GMP regulations. Conduct the EM following the production procedures to ensure proper gowning for entry into designated production rooms.
• Evaluate Environmental Monitoring Testing media plates for accurate results.
• Perform microbiological testing following the respective SAM for water systems, Raw Materials, In-process, Finished Product, and Stability Samples. Ensure testing results align with cGMP, SOPs, and Bimeda quality standards.
• Prepare and test Media, including growth promotion.
• Identification of isolates from various samples.
• Document work in master production records, logbooks, data sheets, as applicable.
• Assist in writing and reviewing validation protocols, project reports, updating laboratory documentation, SOPs, and test methods.
• Perform out-of-specification investigations, environmental excursion investigations, and deviations according to procedures.
• Conduct trend analysis and contribute to special projects.
• Support continuous improvement programs throughout the company.
• Interface with regulatory and customer auditors during facility inspections.
• Notify the Laboratory Supervisor or Designee promptly of any issues impacting testing timelines or general activities.
• Maintain the equipment calibration schedule and review related data.
• Open change controls and follow up on associated actions.
• Conduct tests for raw material, finished product, in-process, stability, and water testing in accordance with SOPs and SAM, adhering to Good Laboratory Practices (GLP) principles, while meeting assigned test schedules.

COMPETENCIES REQUIRED FOR THE ROLE:

• FOSTERING COLLABORATION/TEAMWORK: Demonstrates the ability to work collaboratively with others, particularly in intellectual activities; Shows the ability to bring groups together effectively; Builds partnerships for global performance. Respects others. Guiding and mentoring junior analysts, leading projects, and sharing expertise with the team.
• INITIATIVE: Identifying what needs to be done and doing it before being asked or before the situation requires it. A commitment to staying updated with the latest advancements in chemical analysis, technologies, and methodologies.
• ADAPTABILITY: The ability to adapt to changes in the work environment, approach challenges with flexibility, and adjust strategies to achieve optimal results. Demonstrates resilience in the face of unexpected obstacles or changing priorities.
• PROBLEM-SOLVING: Addressing chemical challenges by utilizing critical thinking and troubleshooting skills. Demonstrates the ability to assess information critically and suggest practical solutions. Precision and accuracy in conducting experiments, analyzing data, and interpreting results remain pivotal in chemical analysis.
• COMMUNICATION: Written and Verbal Communication: The ability to write clear, concise, and comprehensive reports, documentation, and emails. Effectively communicating involved findings to technical and non-technical stakeholders with proficiency in both written and spoken expression.