Your primary responsibilities will include providing specialized knowledge and technical support in quality assurance and control processes within the organization. You will analyze quality data, develop best practices, and advise teams on compliance with industry standards and regulations.

Additionally, you will collaborate with various departments to implement quality improvement initiatives and conduct training sessions. You will ensure compliance, accuracy, standardization, and completeness of documentation supporting products manufactured and packaged at the Myerstown site, including OTC and Nutritional facilities.

You will also support Bayer internal audits, Corporate Technical Audits, State GMP Health inspections, FDA, DEA, and foreign regulatory inspections, as required.

As a Compliance Support Documentation Specialist, you will own the accuracy and cross-functional review of IQMS documents. You will manage periodic reviews of OTC and Nutritional Manufacturing and Packaging documents, including SOPs, Form Sheets, Supplements, and Standardized Documents.

You will collaborate regularly with cross-functional leaders, SMEs, and site team members at all levels to gather input and feedback. You will partner with the Compliance Support Specialist to investigate discrepancies and deviations in accordance with site policies and procedures, including root cause analysis and corrective actions.

You will review Global SOPs, assess impact to local procedures, and define actions required to maintain compliance.

You will apply a proactive, continuous improvement mindset to enhance Safety, Quality, Compliance, Efficiency, and procedural training across the site.

You will comply with all workplace standards, safety requirements, cGMPs, OSHA regulations, SOPs, and company guidelines.

You will support training development and training effectiveness; identify and evaluate future training needs and opportunities.

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