Manufacturing Technologist I or II
About The Position
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.
Requirements
- Bachelor’s degree in Molecular Biology or a closely related field
- Self-motivated to work in a fast-paced environment with a high level of accuracy
- Strong 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)
Nice To Haves
- Wet lab experience preferred but not required
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
