Specialist, Quality Control
About The Position
The Laboratory Specialist within the Quality Operations department, with guidance from the Associate Director of Quality Operations, provides support to Laboratory Operations. The Laboratory Specialist will support sample tracking and scheduling, perform performance trends, manage inventory, facilitate collaboration meetings, engage in project work, and support other business needs at the direction of the Associate Director. The Laboratory Specialist will work closely with the assigned laboratory in a team environment to ensure timely turnaround of laboratory testing and to ensure that documentation is completed right the first time. The Laboratory Specialist will work with Laboratory Operations staff and management coordinate day-to-day schedule and perform historical performance trends. They may also assist Laboratory Operations in conducting investigations associated with sample scheduling or other related topics. Additionally, the Laboratory Specialist will also support project work as needed and lead collaboration meetings within the department and participate in those outside the department. The Laboratory Specialist will also be trained to support Quality Assurance system functions and to support End to End Quality Operations as needed.
Requirements
- Minimum 1-2 years' experience in GMP Manufacturing environment, Pharmaceutical / Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.
- Adaptability
- Analytical Instrumentation
- Biological Sciences
- Driving Continuous Improvement
- GMP Compliance
- Laboratory Documentation
- Laboratory Safety
- Problem Solving
- Teamwork
- Technical Issues
- Troubleshooting
- Use of Laboratory Equipment
- Written Communication
Nice To Haves
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.
- Demonstrated analytical aptitude, critical thinking skills and problem solving skills.
- Demonstrated ability to upskill / coach others.
- Strong written and verbal communication skills.
- Strong organizational skills.
- Experience in pharmaceutical laboratory operations or related environment
Responsibilities
- Responsible for the scheduling of lab testing and performing sample tracking from receipt to approval.
- Maintain metrics and tracking associated with this testing and approval.
- Complete remediation activities for all samples, to ensure roadblocks are appropriately corrected in a timely manner.
- Actively participate in the Tier process and use this forum to make concerns visible and to partner with Laboratory Quality on resolution.
- Facilitate collaboration meetings with the Quality team to drive on-time testing and participate in meetings with external customers to provide testing updates.
- Collaborate with team members in the identification and implementation of continuous improvement initiatives and action plans.
- Support activities in the areas of cost containment, efficiency, productivity, energy conservation, waste minimization, operational excellence, and lean practices.
- Work with members from Quality and Technical Services to properly handle unplanned events impacting laboratory samples.
- Maintain media inventory.
- Participate in design and implementation of training and development programs.
- Foster a customer service attitude across the network.
- Assist with training of incoming personnel.
- Provide support to Regulatory Agency inspections as needed.
- Develop, Update and Modify SOP’s as needed.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
