Position Overview:
We are seeking a proactive and detail-oriented Technical Specialist to join our team. This role is essential in diagnosing and resolving technical issues, managing routine analysis, and ensuring that all documentation and procedures adhere to regulatory standards. You will play a critical role in validating and transferring testing methods, as well as guiding junior team members in their development.
Key Responsibilities:
- Execute and document tests using established procedures and validated methods within a compliant GMP environment.
- Utilize a variety of analytical techniques, including but not limited to Infrared Spectroscopy, UV/Visible Spectroscopy, Gas Chromatography, High Performance Liquid Chromatography, Ultra High Pressure Liquid Chromatography, Atomic Absorption Spectroscopy, and Dissolution Testing.
- Address and document any deviations or nonconformance issues, preparing comprehensive reports and updates in Trackwise.
- Lead or participate in special projects involving testing, data analysis, and report preparation.
- Collaborate with external vendors to secure necessary maintenance documentation and assess third-party test methods for internal application.
- Develop and refine test protocols, SOPs, and standards, including drafting and revising these documents as needed.
- Conduct troubleshooting for instruments and testing methods and perform investigative analyses as required.
- Provide training and mentorship to junior staff, ensuring they are proficient in various methodologies and compliance requirements.
- Maintain meticulous records and review lab notebooks to ensure accuracy and adherence to testing protocols.
- Keep training logs up-to-date and assist in revising procedural documents.
- Contribute to a team-oriented environment and uphold all safety and company policies.
- Adapt to varying work schedules and undertake additional responsibilities as assigned.
Qualifications:
- Bachelor’s Degree in Chemistry, Biology, or a related scientific field.
- 2-5 years of experience in an analytical laboratory within a GMP setting.
We are looking for someone with a strong technical background, excellent problem-solving skills, and the ability to work collaboratively. If you thrive in a dynamic environment and are committed to maintaining high standards of quality and compliance, we encourage you to apply.
