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Regulatory Compliance Associate
2 months ago
Hobson Prior is seeking a highly skilled Quality Control Specialist to join our team in a Quality Control Analytical Laboratory setting. The successful candidate will be responsible for performing quality control testing in accordance with standard procedures and guidelines.
This role may also involve overseeing the work of other staff members in the quality control department, ensuring that all testing is conducted in a timely and efficient manner.
The Quality Control Specialist will be responsible for:
- Establishing and maintaining procedures for quality control testing, ensuring compliance with regulatory requirements.
- Maintaining systems related to in-process, final product, and stability sample testing, ensuring accuracy and reliability.
- Reviewing testing data from other analysts, identifying trends and areas for improvement.
- Assisting with the upkeep of the QC laboratory and its equipment, ensuring optimal performance.
- Performing quality control testing of raw materials, in-process materials, water, and product samples, ensuring compliance with regulatory requirements.
- Reviewing and completing documentation in accordance with good manufacturing practices, ensuring accuracy and completeness.
- Assisting with audits and regulatory inspections, ensuring compliance with regulatory requirements.
- Coordinating the shipping of samples to various locations and testing laboratories, ensuring timely and efficient delivery.
- Assisting with training others within the department, ensuring knowledge transfer and compliance with regulatory requirements.
Key Skills and Requirements:
- A degree in Chemistry, Biochemistry, Microbiology, or another related field.
- Experience in a GLP or/and GMP environment, with a strong understanding of regulatory requirements.
- Computer literacy, including proficiency in MS Word and Excel, with experience in laboratory information management systems (LIMS).
- Ability to work well with others, communicate effectively, and provide excellent customer service.
- Good organizational skills, with the ability to prioritize tasks and manage multiple projects simultaneously.