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Laboratory Specialist
2 months ago
Source One Technical Solutions is seeking a highly skilled Laboratory Technician to join our team as a consultant with a medical device and ophthalmic product manufacturer in the United States. This role will require the individual to work on-site and will involve executing SOPs and protocols for large batch preparation of formulations and intermediate solutions.
Key Responsibilities- Perform daily functions in batch preparation of formulations and intermediate solutions.
- Perform manufacturing batch record review.
- Provide basic maintenance to GxP equipment.
- Complete all necessary inventories and documentation for batch preparation.
- Help with chemical inventory for materials.
- Complete all documentation following the preparation of the batches throughout the process.
- High level of communication between the GxP lab employees and the research, development, and Pilot teams.
- Assist with any additional projects assigned by Cross functional teams.
- Foster a culture of inclusion, efficiency, and compliance within the GxP lab and research group.
- Working knowledge in MS Office Suite, including Word and Excel.
- Must be detail oriented and have excellent hand-eye coordination.
- Working knowledge of cGMP requirements.
- Must be willing to 'Lead by Example'.
- Effective teamwork and communication skills.
- Ability to meet strict deadlines and work under pressure.
- Flexibility in accepting work assignments as required by the needs of the business.
The individual will be required to work in a laboratory environment and will be exposed to hazardous materials. The individual will be required to wear/use the appropriate personal protective equipment (PPE) for the task in hand outlined in SOP's including items such as lab coat, eye protection and gloves. The job requires the handling of materials that come under COSHH guidelines.
Qualifications- 2 years of cGMP experience is required.
- 2-4 years of laboratory experience.
- Medical Device or related regulatory industry experience is preferred.
- High School Diploma/GED is required.
- Associate's or Bachelor's degree in Science discipline is encouraged.