At Bayer, we're seeking a Compliance Support Documentation Specialist to join our team in Myerstown, Pennsylvania. As a Compliance Support Documentation Specialist, you will serve as the Subject Matter Expert (SME) for SOPs and Supplements within OTC and Nutritional Manufacturing and Packaging departments.
\nYour 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.
\nAdditionally, 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.
\nYou will also support Bayer internal audits, Corporate Technical Audits, State GMP Health inspections, FDA, DEA, and foreign regulatory inspections, as required.
\nAs 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.
\nYou 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.
\nYou will review Global SOPs, assess impact to local procedures, and define actions required to maintain compliance.
\nYou will apply a proactive, continuous improvement mindset to enhance Safety, Quality, Compliance, Efficiency, and procedural training across the site.
\nYou will comply with all workplace standards, safety requirements, cGMPs, OSHA regulations, SOPs, and company guidelines.
\nYou will support training development and training effectiveness; identify and evaluate future training needs and opportunities.
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\nThe ideal candidate will have a track record of excellence as a Research Assistant or CRC or other similar role, including developing successful relationships with providers.
\nKey responsibilities include:\nActing as senior study coordinator to execute trials conducted within physician practices,\nConducting patient recruitment and enrollment of eligible patients,\nLeading patient study visits, which may also include clinical and lab procedures,\nIndependently administering the informed consent process with care and quality,\nEnsuring protocol adherence and high data integrity,\nProviding high quality source data capture and documentation,\nSupporting study start-up and planning, including PSVs and SIVs,\nFacilitating monitoring visits (IMVs) and sponsor correspondence,\nManaging the follow-up process,\nIP management, dispensation and accountability,\nAdverse Event management, tracking, and follow-up,\nData entry to CRF/EDC and query resolution in a timely manner,\nSupporting study close-out, including COVs,\nProtocol deviation tracking, reporting, and reconciliation,\nTraining and mentoring junior research staff,\nUsing and helping improve Topography’s proprietary tool set,\nUnderstanding and complying with all regulations, policies, and guidelines applicable to clinical research, including our SOPs,\nEnsuring adherence to study protocols while ensuring trial staff maintain meticulous accuracy in completing all documentation,\nConducting Quality Control activities including routine QC checks during and following study visits,\nAny other duties assigned by manager.
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\nKey responsibilities include acting as a research assistant to clinical trials conducted within physician practices, visit preparation activities, visit follow-up activities, supply and inventory coordination, third-party vendor coordination, patient recruitment and identification, and assisting with patient study visits.
\nThe ideal candidate will have a high school diploma or equivalent, knowledge of FDA regulations and ICH/GCP guidelines, and the ability to draw blood, run labs, and take vitals. Strong communication skills, teamwork, cooperation, self-awareness, and flexibility are also required.
\nThis role will be evaluated on patient experience, protocol management and adherence, and data quality. The successful candidate will lead with empathy for patients and care deeply about creating new access to clinical research in communities across the country.
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