- Carries out duties in compliance with established business policies.
- Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Perform other duties & projects as assigned.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
Under close supervision, this position is responsible for a variety of manufacturing support functions involving the operation of lab equipment and conduct of procedures/tasks according to established GMP, under the direction of senior staff.
Tasks and responsibilities:
- Carry out production tasks in support of manufacturing goals and objectives.
- Production of complex reagents as directed, following established guidelines and procedures.
- Uses chromatography techniques.
- Performs quality control testing.
- Participates in Lean Activities.
- Operates complex laboratory equipment.
- Operate laboratory equipment safely, as trained and directed, and in accordance with established practices.
- Maintain records and notebooks as directed in a neat, thorough and accurate manner. Perform required data entry on company planning and materials management system. Report results to supervisor.
- Maintain a neat and organized workplace. Ensure materials are appropriately labeled, approved for use and in sufficient quantity to complete required tasks.
- Recommend and participate in document revisions to ensure accurate BOMs and process descriptions.
- Recommend and participate in document revisions as actions for non-conformance/NCMR process.
- Operate moderately complex laboratory equipment and perform routine maintenance/repair. Interface with contracted repair technicians as required.
- Follow all safety guidelines, manufacturing policies and procedures. Operate under strict QSR and ISO compliance.
- Perform complex formulations, component and material evaluations, equipment calibrations and maintenance.
- Participate in product/process troubleshooting and validations.
- Carry out functions which may require multiple task coordination.
- Cover on call assignments. Comply will all restrictions and requirements.
- BA or BS degree minimum
- Preferred degree in Chemistry or Biological Sciences.
- Two to four years' experience (BA/BS) or zero to one years' experience (MA/MS).
- Ability to follow detailed instructions, maintains accurate records and notes, and carries out assignments in a thorough, conscientious fashion while adhering to safe laboratory practices.
- Knowledge of a variety of lab equipment and their operation is preferred.
- Able to carry out experiments following established guidelines and summarize results accurately.
- Demonstrate problem-solving and troubleshooting skills
- Strong verbal and written communication skills
- Organized and detail oriented
- Knowledge and ability to use MS Office and common laboratory software
- Ability to work in a team environment
All listed tasks and responsibilities are deemed as essential functions to this position; however, reasonable accommodations will be made if at all possible under business conditions.