This position is responsible for completion of testing on finished products to ensure they meet our regulatory requirements. This individual should be able to understand and execute testing processes as defined in work instructions or standard operating procedures with limited supervision or guidance.
We are seeking a self-motivated individual with strong communication and operational skills to perform daily tests. This individual will coordinate these activities to ensure they are completed in an efficient manner and key customer expectations are met on time and in full. Candidate must be able to work independently, as well as on teams within the cell culture, Microbiology, Analytical, Incoming Quality, and Environmental Quality Control Laboratories. Must have the ability to multitask in a fast paced environment and prioritize work as necessary.
Key Objectives of the role:
- Upholds departmental standards as required in a GMP environment
- Manages individual workflow of daily tests and activities to ensure departmental goals are met
- Required to work on tasks of moderate scope where analysis of situations or data requires problem solving skills.
- Interacts with cross functional internal customers at all levels of the organization for resolution of issues
- Supports training and cross-training efforts for team development
- Position is for 1st shift, Tuesday – Saturday
Minimum Qualifications (must have):
- Requires a full functional knowledge of the laboratory equipment and technique.
- Minimum of AAS degree in Microbiology, Biology, or Environmental Sciences. Bachelor’s degree preferred.
- Candidate must be able to work independently, as well as on teams within the Cell Culture, Analytical Chemistry, Microbiology, Environmental and Incoming Quality Control Laboratories.
- Must have the ability to multitask in a fast paced environment and prioritize work as necessary.
- Excellent computer skills, display specific expertise in Excel
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- Responsible for running in-process, stability/calibration, final release, and experimental devices
- Notifying appropriate personnel of results and completing all associated data and documentation
- Cross-trained on all processes including in-process, stability, calibration, and final release
- Able to solve process-related questions/problems and minor investigations
- Review device history records
- Train new employees/Quality Control Technician I
- Operate laboratory equipment safely, as trained and directed, in accordance with established practices
- Responsible for inventory of all testing related materials
- Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies
- 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
- 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; build productive internal/external working relationships
- Carries out duties in compliance with established business policies
- Other duties as assigned, according to the changing needs of the business
MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:
- BS in a science-related field
- 2 – 5 years of laboratory experience in quality control/assurance or a manufacturing environment, preferably invitro diagnostics
- Proficient with Microsoft Office Suite; strong knowledge of Excel
- Organized and detail oriented
- Ability to work in a team environment
- Able to multitask and adapt to changes in task priorities
- Continually develops his/her own skillset.
- Acts ethically and takes accountability for achieving outcomes.
- Actively develops a network to bring best solutions to the team or customer.