Container Closer Integrity Test (CCIT) Laboratory Analyst
Container Closer Integrity Test (CCIT) Laboratory Analyst
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Salary Not Disclosed
1 Vacancy
Job Description
The Container Closure Integrity testing laboratory analysts in the Analytical Quality Control Operations (AQCO) organization will serve as a technical resource to execute container closure test method validations and transfers to support installation of CCIT in Quality Control testing labs both within client and at contract partners. The CCIT analyst has primary responsibility for executing approved protocols for method validation and transfer generating the data necessary to complete studies training analysts in receiving laboratories and participating in investigations of protocol deviations or protocol execution issues. The analyst may also participate in generating documentation including methods protocols reports and change controls in support of these activities. The CCIT analyst should have familiarity with basic laboratory operations and must be capable of operating in a cGMP laboratory environment.
- Execute approved protocols for method validation and transfer with accurate documentation of execution steps and data in an electronic notebook or other electronic execution system.
- Provide hands-on training and oversight to receiving laboratories before and during method transfers including troubleshooting for execution difficulties.
- Assist with investigations into protocol or method execution errors or difficulties in successful testing.
- Author methods protocols and reports to support new molecules or transfer existing methods to new laboratories.
- Technically review validation or transfer data generated by other analysts.
Qualifications :
- Bachelors degree in chemistry or related physical sciences field or at least 3-5 years of laboratory experience in a cGMP pharmaceutical Quality Control laboratory.
- Fundamental knowledge of and experience in a cGMP environment.
- Effective communication (oral and written) attention to detail and self-management
- Exceptional interpersonal skills with ability to work within a cross-functional interdisciplinary team environment
- Strong computer scientific and organizational skills
- Ability to work independently and as part of a team self-motivation adaptability and a positive attitude
- Ability to learn new techniques perform multiple tasks simultaneously keep accurate records follow instructions and comply with company policies
Additional Skills/ Preferences:
- Experience using Electronic Laboratory Notebooks and electronic document repositories.
- Prior experience with Container Closure Integrity testing.
Additional Information :
Position is Monday- Friday 8:00 am- 5:00 pm. Overtime as needed. Candidates currently living within a commutable distance of Indianapolis IN are encouraged to apply.
- Excellent full-time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- #LI-EB1
- Authorization to work in the United States indefinitely without restriction or sponsorship
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
