Data Integrity Specialist

• Research Laboratory and Manufacturing processes to develop compliance gap assessments related to data integrity.
• Understand Laboratory and Manufacturing data life cycles to develop data maps.
• Report on progress of data integrity work and significance of the results.
• Complete Periodic System Reviews according to schedule, working with system administrators and subject matter experts to accurately assess the systems and the associated data.
• Assess risks related to data integrity and collaborate with colleagues to mitigate and implement appropriate corrective actions.
• Assist Laboratory and Manufacturing personnel with development of procedures, job aids and other documentation to improve the overall site compliance stance.
• Utilize expertise and information on data integrity to assist Laboratory and Manufacturing personnel oncompliance issues.
• Maintain current knowledge of federal and international data integrity regulations.
• Author SOP's
• Create data maps for laboratory and manufacturing systems.
• Assist site staff in adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines.

• Bachelor Degree preferred. Work experience is considered in lieu of degree.
• Three or more years of relevant work experience required.
•  Must understand how to apply regulations within manufacturing and laboratory environments.
• Experience reviewing / authoring SOP's

#IND-SPG

Estimated Min Rate: $28.00
Estimated Max Rate: $35.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20 hours per week)
• Health Savings Account (HSA) (for employees working 20 hours per week)
• Life & Disability Insurance (for employees working 20 hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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