Lab Technician II - GMP

Contenuto del lavoro

Responsibilities

• Strictly adhere to customer specific as well as general work instructions and SOPs.
• Strictly adhere to protocols outlined by all related GMP documentation and rules.
• Effectively identify the need for documentation/process changes, process deviations, product non-conformances, and other occurrences that can indicate the ineffectiveness of quality and/or manufacturing systems.
• Effectively identify features and characteristics of processes and products that bear on the ability of the finished product to satisfy fitness-for-use, including safety and performance.
• Maintain a constant awareness for product defects, which may occur from the improper performance of specific tasks.
• Adhere to all requirements for the health, cleanliness, personal practices, and clothing of personnel if contact between such personnel and product or environment could reasonably be expected to have an adverse effect on product quality.
• Perform the cleavage from the solid support, deprotection, concentration, quantification and QC sampling of oligonucleotides.
• Keep all the reagent bottles, waste containers at levels to achieve successful operation.
• Operate various spectrophotometers and liquid handling equipment to quantify and formulate oligos to customers’ specifications.
• Prepare standard or customized final shipment documentation.
• Process paperwork necessary for the formulation, processing, and shipping of final product.
• Interpret QC results and recognize when failures warrant further investigation.
• Review the Deprotection / Formulation process on individual oligos for accuracy.
• Perform all necessary decontamination procedures.
• Fill out all required checklists and perform verification for others when necessary.
• Participate in customer and regulatory audits.
• Report any problems to Management.
• Conduct tasks assigned by Management.
• Be aware of IDT’s policy on and contribute to quality and environmental management by adhering to the requirements of the ISO 9001, 13485 and 14001 standards and internal procedures and work instructions.
  

Job Qualifications

• Must have at least a Bachelor’s degree in a Science related field or equivalent through experience.
• Must have excellent computer skills which includes knowledge of the Internet, Microsoft Excel and Microsoft Word.
• Must be able to adhere to defined protocols.
• Must be able to give strict attention to details.
• Must be able to be on feet a few hours at a time.
• Must possess the ability to adapt to changes in the process.
• Must possess the ability to work in a fast-paced environment.
• Must be able to multi-task.
• Must be able to interact in a professional manner with customers, employees and all levels of management.
• Must be able to work in a group or independently.
• Must be able to read, write and speak English fluently. Other languages are a bonus.
• Must be able to work over 40 hours per week, if required.
• Must be able to lift 12 kg.
  

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you’ve ever wondered what’s within you, there’s no better time to find out.

Responsibilities

Strictly adhere to customer specific as well as general work instructions and SOPs. Strictly adhere to protocols outlined by all related GMP documentation and rules. Effectively identify the need for documentation/process changes, process deviations, product non-conformances, and other occurrences that can indicate the ineffectiveness of quality and/or manufacturing systems. Effectively identify features and characteristics of processes and products that bear on the ability of the finished product to satisfy fitness-for-use, including safety and performance. Maintain a constant awareness for product defects, which may occur from the improper performance of specific tasks. Adhere to all requirements for the health, cleanliness, personal practices, and clothing of personnel if contact between such personnel and product or environment could reasonably be expected to have an adverse effect on product quality. Perform the cleavage from the solid support, deprotection, concentration, quantification and QC sampling of oligonucleotides. Keep all the reagent bottles, waste containers at levels to achieve successful operation. Operate various spectrophotometers and liquid handling equipment to quantify and formulate oligos to customers’ specifications. Prepare standard or customized final shipment documentation. Process paperwork necessary for the formulation, processing, and shipping of final product. Interpret QC results and recognize when failures warrant further investigation. Review the Deprotection / Formulation process on individual oligos for accuracy. Perform all necessary decontamination procedures. Fill out all required checklists and perform verification for others when necessary. Participate in customer and regulatory audits. Report any problems to Management. Conduct tasks assigned by Management. Be aware of IDT’s policy on and contribute to quality and environmental management by adhering to the requirements of the ISO 9001, 13485 and 14001 standards and internal procedures and work instructions.