Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Andover

Description

Cognizant is
hiring "
Data Integrity Analyst for Andover,
MA
location”. Interested candidates who are local and
willing to relocate can apply.
Job Title:
Data Integrity Analyst
Job
Location:
Andover, MA
Mandatory
skills:
• 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
Preferred
Skills:
·
Bachelor’s Degree in engineering or
life sciences
·
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
skills
Job Roles
and Responsibilities
The individual will provide Quality Assurance
oversight in support of a site project to remediate Data Integrity (DI)
commitments.
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
remediation activites.
The documentation
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
manufacturing.
·
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.
Technical Skills
SNo
Primary Skill
Proficiency Level *
Rqrd./Dsrd.
1
Testing Frameworks
PL1
Required
* Proficiency Legends
Proficiency Level
Generic Reference
PL1
The associate has basic awareness and comprehension of the skill and is in the process of acquiring this skill through various channels.
PL2
The associate possesses working knowledge of the skill, and can actively and independently apply this skill in engagements and projects.
PL3
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.
PL4
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
Shift :
Day Job
Travel :
No
Job Posting :
Mar 20 2019
Cognizant US Corporation is an Equal Opportunity Employer Minority/Female/Disability/Veteran. If you require accessibility assistance applying for open positions in the US, please send an email with your request to
CareersNA2@cognizant.com
About Cognizant
Cognizant is one of the world's leading professional services companies, transforming clients' business, operating and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant, a member of the Nasdaq-100, is ranked 195 on the Fortune 500 and is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at
www.cognizant.com
or follow us on Twitter:
USJobsCognizant.
Cognizant is recognized as a Military Friendly Employer and is a coalition member of the Veteran Jobs Mission. Our Cognizant Veterans Network assists Veterans in building and growing a career at Cognizant that allows them to leverage the leadership, loyalty, integrity, and commitment to excellence instilled in them through participation in military service.

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.

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