- Entry level
- No Education
- Salary to negotiate
Data Integrity Analyst for Andover,
location”. Interested candidates who are local and
willing to relocate can apply.
Data Integrity Analyst
• Proficient in reviewing executed validation
documents (change controls, protocols and test plans, validation testing
documents, deviations, etc.)
• Knowledge of cGMP regulations as they pertain to
the pharmaceutical/biopharmaceutical industry.
• Thorough understanding of the computer validation
lifecycle, including change control
• Identify and address any potential quality impact
throughout the project
Bachelor’s Degree in engineering or
5 years of computer validation/QA
experience in a GMP environment
Experience with change control as a
Quality Assurance approver
1 year of experience with Trackwise
change control software (or similar)
Strong experience in working with
cross functional teams
Excellent teamwork, flexibility and interpersonal
The individual will provide Quality Assurance
oversight in support of a site project to remediate Data Integrity (DI)
The individual will be
responsible for the quality review and approval of validation and change
control documentation such as protocols, test plans, various computer
validation testing documents, deviations, and change controls in relation to DI
will span the breadth of validation and change control requirements for
biopharmaceutical processing therefore validation and quality assurance
experience in an manufacturing GMP environment is required. The individual will
also ensure that the execution of documents adheres to the governing SOPs,
protocols, project plans, cGMP, etc. Upon completion of their review, the
individual will also be responsible for the release of equipment back to GMP
Provide QA review of executed
validation documents such as change controls, protocols and test plans,
validation testing documents, and deviations.
Ensure compliance to governing SOPs,
validation plans, and protocols throughout the project.
Release equipment back to GMP
manufacturing as part of change control.
Have the ability to independently
assess impact and re-testing requirements in the event of a deviation.
Proficiency Level *
* Proficiency Legends
The associate has basic awareness and comprehension of the skill and is in the process of acquiring this skill through various channels.
The associate possesses working knowledge of the skill, and can actively and independently apply this skill in engagements and projects.
The associate has comprehensive, in-depth and specialized knowledge of the skill. She / he has extensively demonstrated successful application of the skill in engagements or projects.
The associate can function as a subject matter expert for this skill. The associate is capable of analyzing, evaluating and synthesizing solutions using the skill.
Employee Status :
Full Time Employee
Job Posting :
Mar 20 2019
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About the company
Cognizant (NASDAQ: CTSH) is a leading provider of information technology, consulting, and business process outsourcing services, dedicated to helping the world's leading companies build stronger businesses. Headquartered in Teaneck, New Jersey (U.S.), Cognizant combines a passion for client satisfaction, technology innovation, deep industry and business process expertise, and a global, collaborative workforce that embodies the future of work. With over 100 development and delivery centers worldwide and approximately 221,700 employees as of December 31, 2015, Cognizant is a member of the NASDAQ-100, the S&P 500, the Forbes Global 2000, and the Fortune 500 and is ranked among the top performing and fastest growing companies in the world. Visit us online at www.cognizant.com or follow us on Twitter: Cognizant.