Container Closer Integrity Test CCIT Laboratory Analyst

Eurofins USA PSS Insourcing Solutions; New York (NY); On-site; USD 65,000 - 85,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Container Closure Integrity Testing Laboratory Analyst to execute method validations and provide training in a cGMP environment. This role requires a strong educational background in chemistry or relevant experience in Quality Control laboratories. The analyst will ensure compliance with protocols and contribute significantly to testing processes within the organization. Comprehensive benefits and a supportive working environment are offered.

Benefits

Comprehensive medical coverage

Dental and vision options

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Qualifications

• Bachelor’s degree required or 3-5 years cGMP lab experience.
• Knowledge of cGMP environment essential.
• Effective communication, attention to detail, and interpersonal skills vital.

Responsibilities

• Execute approved protocols for method validation and transfer.
• Provide training and troubleshooting support to laboratories.
• Prepare methods, protocols, and reports for new methods.

Skills

Communication

Attention to detail

Interpersonal skills

Self-management

Adaptability

Organization

Education

Bachelor’s degree in chemistry or related physical sciences

3-5 years of laboratory experience in a cGMP pharmaceutical Quality Control laboratory

Tools

Electronic Laboratory Notebooks

Job description

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:
Qualifications

• Bachelor’s 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
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• 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.