Job Description

Job Responsibilities:

• Perform QC testing to support rapid batch release.
• Participate in training on procedures, safety protocols, and QC methodologies.
• Assist with the qualification and verification of new equipment and software systems.
• Contribute to the creation and review of key documents, such as protocols, standard procedures, and validation plans.
• Support the technical transfer and implementation of QC methods and improvements.
• Conduct QC testing for batch release shortly after production.
• Adhere to safety regulations and standards, including environmental, health, and safety (EHS) guidelines.
• Ensure compliance with regulatory standards, company policies, and operational procedures.
• Verify calibration and qualification status of instruments and equipment.
• Ensure raw materials are within their expiry dates before use.
• Perform system checks on instruments to ensure suitability for testing.
• Conduct various types of testing, such as chemical and microbial analysis on materials and finished products.
• Maintain accurate records and logs for all testing, ensuring compliance with relevant guidelines.
• Identify potential issues with equipment or materials and escalate them when necessary.
• Manage lab supplies, perform inventory checks, and help maintain stock of essential materials.
• Assist with the cleaning of the QC lab and disposal of waste materials.
• Foster a culture of continuous improvement and work towards set objectives and timelines.
• Contribute to the documentation and revision of procedures, including quality assessments and corrective actions.
• Assist in regulatory audits and inspections, and review processes for improvements.
• Support training of new team members and ensure compliance with company standards and regulatory requirements.
• Collaborate with other teams to enhance the effectiveness of the QC process.
• Participate in quality investigations and support efforts to resolve any deviations or issues.

Qualifications:

• Minimum of 3 years of experience in QC, including experience in regulated environments.
• Strong understanding of laboratory safety and compliance with relevant standards.
• Excellent technical skills in testing, instrumentation, and troubleshooting.
• Ability to perform tasks with attention to detail and work efficiently in a fast-paced environment.
• Solid understanding of regulatory requirements and cGMP.
• Strong communication skills and the ability to work in a team.
• Ability to adapt to changing environments and challenges.
• Knowledge of analytical methods, validation processes, and safety regulations.
• Experience with laboratory management systems (LIMS) and various analytical techniques (e.g., HPLC, microbiological testing).
• Strong problem-solving skills and the ability to manage competing priorities.
• Background in radiation safety and OSHA standards.
• BA/BS in Chemistry preferred.

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