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The Manager, Consolidations & Financial Reporting oversees the monthly and quarterly consolidation of financial statements, ensuring data integrity and timely reporting. This role includes SEC reporting responsibilities, collaboration with various internal teams, and the establishment of standard operating procedures. The Manager acts as a key resource for the Finance organization, driving effective financial reporting practices and identifying enhancements in reporting applications.
The Senior Quality Control Engineer will oversee Computer System Validation activities and ensure compliance with data integrity for Quality Control software and equipment. Responsibilities include managing validation plans, resolving compliance issues, and supporting regulatory inspections and audits.
The Key Account Specialist will execute the sales process for key customer accounts, focusing on customer relationships, territory planning, and effective call strategies. Responsibilities include developing call plans, maintaining databases, executing administrative tasks, and achieving account objectives while complying with regulatory standards.
The Senior Research role involves reviewing Analytical Lab data for accuracy and compliance with cGLP and regulatory standards. The candidate will ensure quality audits are addressed, manage change controls, and prepare SOPs, all while participating in improvement initiatives and supporting the ARD department on compliance matters.
The Automation Engineer is responsible for supporting ongoing manufacturing processes, developing/designing manufacturing processes for new products, and ensuring effective communication and coordination between all participating departments. Primary objective is to ensure that manufacturing processes are capable, compliant, in control, and continuously improved.
The role involves analyzing stability samples and managing their upkeep, as well as monitoring stability chambers.
The Tax Manager will oversee the preparation and review of the global tax provision according to ASC 740, including U.S. federal, state, and local income tax returns. Responsibilities include quarterly tax provision calculations, Form 10Q and 10K disclosures, global tax compliance coordination, and mentoring tax staff in a timely and accurate manner.
The Principal Quality Lead oversees complex quality validation projects and leads multi-functional teams. Responsibilities include analysis, compliance with cGMPs, mentoring junior engineers, and ensuring quality standards through validation and qualification activities.
The Senior Quality Manager Compliance is responsible for overseeing site Quality Systems and compliance, ensuring adherence to cGMP and FDA regulations. This role involves leading audits, managing change control, overseeing product complaints, and mentoring quality assurance staff to foster a culture of continuous improvement and accountability within the team.
The Senior Tax Analyst is responsible for preparing and reviewing the company's global tax provision according to ASC 740, preparing federal and state tax returns, managing the tax compliance process, and identifying opportunities for automation. This role also assists with tax planning and the development of junior team members.
The Senior Quality Specialist, Systems monitors and analyzes quality systems, tracks Non-Conformances and Complaints, and ensures compliance with regulations. The role involves preparing metrics for Quality Management Review and coordinating with various departments to drive continuous improvement in quality processes.
The Senior Quality Specialist ensures compliance with domestic and international GMP regulations, supports all quality operations related to development and manufacturing, reviews quality documentation, and trains junior QA team members. The role involves collaborating with management and suppliers to resolve quality issues and improve quality systems.
The Financial Systems Manager oversees the management of financial systems, specifically SAP and OneStream. Responsibilities include support for end-users, identifying and implementing system improvements, coordinating month-end and year-end closures, and ensuring compliance with GAAP and financial standards.
The Process Engineer I performs duties related to optimization and analysis of production processes, new products, processes, and technology transfers. Responsibilities include preparing and executing engineering study protocols, conducting formulation development, troubleshooting manufacturing/packaging equipment, and conducting training for department personnel.
The Quality Specialist, Systems is responsible for monitoring and analyzing Non-Conformances, CAPA, and complaints within the quality systems. This role includes assessing risks associated with these issues, providing necessary metrics for quality reporting, and ensuring compliance with corporate standards. Key tasks involve continuous improvement efforts and collaboration with management to evaluate quality processes.
The Research Associate will conduct laboratory experiments, support API development through feasibility studies, identify critical process parameters, optimize processes, validate lab batches, perform literature reviews, and synthesize assigned impurities, focusing on nitrosamine assessment.
The Trainee in L&D will assist in designing and executing training programs, coordinating sessions, managing training records, evaluating training effectiveness, and providing administrative support to the L&D team. The role includes analyzing training data, collaborating with subject matter experts, and overseeing special projects.
The Analyst, Quality Control will perform testing and monitoring activities related to water sampling, environmental conditions, and microbial testing. The role requires expertise in maintaining microbial cultures and ensuring adherence to USFDA compliance standard practices.
The Sr Associate will engage in batch manufacturing and filling activities, focusing on sterile dosage and packaging operations. The role requires technical expertise in aseptic processes, bulk manufacturing, and operation of equipment such as sterileizers and filling lines.
Assist in the day-to-day operations of the Analytical Research & Development Laboratory, focusing on analytical method development and reverse engineering of injectable dosage forms. Responsibilities include analysis and characterization, troubleshooting analytical issues, method validation, transferring methods to manufacturing, and preparing development documentation.