We are hiring for a Manufacturing Technologist I. This role will perform tasks supporting the manufacturing of diagnostic medical products in a highly regulated environment and in accordance with established procedures and maintain a work environment consistent with PCR and NGS manufacturing.
Duties and Responsibilities
- Manufacturing of semi-finished and finished goods to support company needs. This includes the manufacture of reagent fills and building finished good kits.
- Adhere to pre-defined manufacturing work instructions.
- Ensure complete and accurate documentation.
- Maintain a clean and orderly workstation and lab space.
- Contribute to and review SOPs and any required Quality Management System documentation as needed.
- Maintain general lab systems. This includes performing daily, weekly, monthly, or as needed lab cleaning, equipment maintenance, and inventory.
- Comply with established health and safety procedures and policies.
- Adhere to all OSHA Safety and FDA Regulatory standards.
- Identify and report procedural deviations, nonconformances, and out of specification products.
- Respond with appropriate investigation and corrective/preventive actions as needed.
- Contribute to process improvements of current systems within the department.
- Perform all other duties as needed.
Qualifications
- Bachelor’s degree preferred but not required
- Wet lab experience preferred but not required
- Self-motivated to work in a fast-paced environment with a high level of accuracy
- Good organizational and time management skills
- Work productively in group situations as well as independently
- Knowledge of Good Documentation Practices
- Good communication (written and oral) skills
- Excellent recordkeeping and attention to detail
- Proficient with MS Office Suite (Outlook, Excel, and Word)
Working Conditions
- This position is conducted in a mix of manufacturing lab and office environment. Must be able to perform work while sitting or standing for extended periods of time. Position may require repetitive movements.
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Last updated on Dec 18, 2024