Job Title: Quality Investigator
The Quality Investigator will be responsible for performing thorough, detailed, and timely investigations. The individual will develop collaborative relationships with operational leadership and staff across various Business Units and Quality representatives to facilitate investigations using continuous improvement techniques, identify root cause, and implement appropriate Corrective and Preventive Actions (CAPAs). The investigator needs to have experience in Environmental Monitoring and a working knowledge of relevant GMP and FDA regulations. Additionally, the individual should be familiar with LIMS (or an equivalent system) and able to identify trends and aberrant sample results. Prior experience compiling trending data is a plus. Completing investigations in a timely manner, making recommendations on material disposition, determining root cause, and implementing appropriate CAPAs are key responsibilities.
Responsibilities
Perform thorough, detailed, and timely investigations.
Develop collaborative relationships with operational leadership and staff.
Facilitate investigations using continuous improvement techniques.
Identify root cause and implement appropriate CAPAs.
Possess experience in Environmental Monitoring and knowledge of GMP and FDA regulations.
Utilize LIMS (or equivalent system) to identify trends and aberrant sample results.
Compile trending data.
Complete investigations in a timely manner.
Make recommendations on disposition of materials from investigational data.
Determine root cause and implement appropriate CAPAs.
Essential Skills
Environmental monitoring
GMP experience
Root cause analysis
CAPA
Investigation
Bachelor's degree in microbiology or a related life science field
3+ years of experience in the pharmaceutical industry
At least 1 year of experience writing investigations on a routine basis
Experience in the pharmaceutical industry
Additional Skills & Qualifications
Experience with LIMS
Experience with Trackwise
Experience with MODA
Aseptic manufacturing
Microbiology
Media fill
Particulate
Sterility
Aseptic Manufacturing
MODA
Work Environment
The individual will have their own desk space with a laptop but will also be required to walk around the plant to track down people for interviews, shadow processes, and pull samples and data from the appropriate individuals.
Pay and Benefits
The pay range for this position is $35.00 - $45.00
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Wilson,NC.
Application Deadline
This position will be accepting applications until Jan 24, 2025.
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 *** (%***) for other accommodation options.
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