Data Integrity Specialist

Yoh is hiring a Data Integrity Specialist for our Pharmaceutical Manufacturing client in St. Louis, Missouri. Essential Job Functions 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 on compliance 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. Education and Experience Requirements 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. Estimated Min Rate: $28.00 Estimated Max Rate: $35.00 Benefits 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. #J-18808-Ljbffr