Senior Quality Technician

Description:

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 datesInitiates 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 samplesHelp with stocking, sorting, and tote samplesLogging data into SAP, Labware, and Inventory Management

Skills:

science, Sample prep, documentation process, Quality assurance, Regulatory, Sorting, Laboratory, Quality inspection, Regulatory affairs

Top Skills Details:

science,Sample prep,documentation process,Quality assurance,Regulatory

Additional Skills & Qualifications:

Must have HS Diploma, prefer Associates or Bachelors ins Science or Regulatory fieldMust have 2-3yrs of relevant industry experience doing sample management, Quality Assurance, or Regulatory workStrong Communication skillsNeed to be comfortable being on their feet for majority of their shift and walking to many of the different departmentsPrior Inventory management skills a plusComfortable using different software systems and computer skillsMust have strong attention to detail and organization skills

Experience Level:

Intermediate Level

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:

• 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

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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.