Quality Assurance Regulatory Specialist
North America - LENEXA, KS
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PURPOSE OF THE POSITION
The purpose of this job is to ensure Sigma-Aldrich's compliance with government regulations. This includes coordinating with the operational organizations involved to develop consistent, efficient business practices that comply with all pertinent regulatory requirements.
ESSENTIAL JOB FUNCTIONS
Regularly review publications or other information sources including USP/EP/JP monographs to identify regulatory changes or to validate existing procedures (i.e. Federal Register)
Determine impact of regulatory requirements on current or future business practices
File regulatory documents in order to support current or future business practices
Conduct formal and informal training on regulatory requirements, as needed
Work with operations management to implement new/updated procedures
Create/maintain operating procedures for Corporate Compliance
Provide support to project teams, as needed
Initiate necessary changes to operational procedures
Assist with internal compliance audits as needed as well as customer audits
Establish procedures for participating in regulatory inspections (scheduled or unscheduled)
Attend meetings, conferences or inspections with regulatory officials
Respond to inquiries received from regulatory agencies
Initiate all verbal and written correspondence with regulatory officials, as needed
Identify and be familiar with all regulatory reporting requirements
Develop record retention plan to ensure documentation is properly maintained and readily retrievable
Maintain a calendar with due dates for all records, registrations and reports
Review raw materials and raw material specifications to determine impact against internal policies and regulatory guidance documents
Preferred: BSBA Science or Business
Experience in compliance/regulatory activities preferred. Minimum of two years of experience in a regulated industry and/or quality assurance function, or equivalent, preferred.
Skills and Knowledge:
Strong attention to detail.
Strong verbal and written communication skills, with ability to translate technical requirements into more general terms.
Strong time management skills.
Able to facilitate cross-functional teams across various sites and departments.
Self-motivated and able to work independently.
Previous experience working in a regulatory industry either in regulatory or quality assurance functions.
Sigma-Aldrich is a leading Life Science and High Technology company committed to Enabling Science to Improve the Quality of Life. Its chemical and biochemical products and kits are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development and as key components in pharmaceutical, diagnostic and other high technology manufacturing. The Company has customers in life science companies, university and government institutions, hospitals, and in industry. Over one million scientists and technologists use its products. Sigma-Aldrich operates in 40 countries and has 7,900 employees providing excellent service worldwide. For more information about Sigma-Aldrich, please visit its award-winning Web site.
Sigma-Aldrich offers a highly motivational and rewarding working environment with attractive salary, benefits, retirement, relocation and incentive packages including tuition reimbursement. Sigma-Aldrich fosters the growth of employees in a culture of respect and dignity with ample opportunity for career advancement.
Sigma-Aldrich is an Equal Opportunity Employer
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