Qualifications:

Please select Physical Requirements under Skills section.

Responsibilities:

Help with Data Integrity strategy and projects for IFM (Indianapolis Facilities Management) while closely working with functions SMEs, Quality and customers. He/she will be an advocate for data management improvement/sustainment. This requires collaboration with local data management subject matter expert to facilitate and drive improvements in data-related local standards, business processes, and governance necessary for ongoing data integrity effectiveness and efficiency (simplification). This role will partner with functional area data experts to anticipate and resolve key data management and integrity issues while driving solutions that impact the site and align with corporate objectives. This role will leverage understanding of GMP data (electronic and paper), the application of data management and integrity principles in operational processes, and Computer System Validation methodologies to ensure regulatory compliance, consistency, and sustainment. They will help facilitate/drive advancement of data management standards at the site to ensure consistency, facilitate site-wide understanding and a strong data integrity site culture. Develops/re-engineers and/or implements programs/processes which improve overall compliance and quality in Client, third party, or contract operations. Participates in internal audits and help with significant external audits; of audit response. Develops ideas and evaluates ideas for quality and process improvements.

Generates support for ideas (e. g. , through persuasion) among one's team members, peers, business partners, and management. Influences development of strategies, policies, and Data Integrity plan as it relates to quality. Client is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Being on a temporary contractor assignment at Client means working in an innovative culture where you have the opportunity to support the work of thousands of others around the globe dedicated to improving the lives of others. Client discovers and brings life-changing medicines to those who need them, improves the understanding and management of disease, and gives back to communities through philanthropy and volunteerism. Client passionately promotes food security and fosters the human-animal bond to enrich the lives of its customers and the customers they serve as well. Our values: integrity, excellence, respect for people. Greater than 90% of workers rate their Client assignment as above average or excellent. 

Additional Skills:• Knowledge of cGMPs, Data Integrity and quality systems.• Previous experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs.• Project delivery and management skill• Demonstrated strong written and verbal communications skills.• Demonstrated strong problem solving and analytical thinking skills.• Review documents pertaining to Data Integrity/Data Management.• Provide quality guidance and recommendations with respect to Data Integrity matters