- Ensures studies are placed on Stability according to cGMP, SOP's, work instructions, and FDA regulations.
- Applies knowledge of cGMP, FDA regulations, SOPs, and work instructions to ensure studies are started correctly and regulatory compliance is maintained.
- Performs daily stability sample pulling, and ensures appropriate laboratories receive sample on testing due dates
- Initiates and maintains stability studies through LIMS to support annual requirements.
- Maintains up to date inventory on all studies using LIMS.
- Initiates and coordinates destruction and reconciliation of non-class and class samples via LIMS.
- Pull samples from quality chambers, maintain retains, and sort samples
- Help with stocking, sorting, and tote samples
- Logging data into SAP, Labware, and Inventory Management
- HS Diploma, prefer Associates or Bachelors ins Science or Regulatory field
- 2-3yrs of relevant industry experience doing sample management, Quality Assurance, or Regulatory work
- Strong Communication skills
- Comfortable being on their feet for majority of their shift and walking to many of the different departments
- Prior Inventory management skills a plus
- Comfortable using different software systems and computer skills
- Strong attention to detail and organization skills
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Senior Quality Technician - Westerville, United States - Actalent
Description
RESPONSIBILITIES:
REQUIREMENTS:
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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