Description. Job Summary. Manage the Front Desk and all associated responsibilities as detailed below. Performs a variety of administrative tasks including scheduling, reporting and tracking information for site senior management and staff as detailed below. Responsible for visitor management, requiring interaction with both internal and external executives and assistants government regulatory agencies, vendors, and contractors to coordinate a variety of sometimes complex meetings and activities. ? Responsible for conference room calendar management working with both executives ... view job details
Description. Job Summary. Manage the Front Desk and all associated responsibilities as detailed below. Performs a variety of administrative tasks including scheduling, reporting and tracking information for site senior management and staff as detailed below. Responsible for visitor management, requiring interaction with both internal and external executives and assistants government regulatory agencies, vendors, and contractors to coordinate a variety of sometimes complex meetings and activities. ? Responsible for conference room calendar management working with both executives ... view job details
Description. Responsible for overall day-to-day management of the accounting function, including financial information systems, accounts payable, payroll, treasury, fixed assets, and ensuring that proper internal controls are maintained.. Position reports to: Chief Financial Officer.. The primary responsibilities include:. • Provide strategic oversight on accounting operations and financial systems. • Manage financial information systems monitoring and controls. • Deliver accurate and timely financial reports including monthly, quarterly and annual financial statements and management. reports ... view job details
Description. This position is responsible for ensuring compliance with drug enforcement administration (DEA) regulations as well as internal policies and procedures for both Portage, IN and Warren, NJ facilities. This role will contribute to the continuous improvement of the DEA program through regular updates, revisions, and implementation of internal policies. Various DEA related tasks will be performed, by this individual, on a daily basis. Responsibilities. • Evaluate current Controlled Substance operating procedures for inconsistencies, gaps and non-conformances. • Leads and/or assists in... view job details
Description. Job Summary. This position is responsible for ensuring that the Quality Systems Team and site complies to company policies, procedures, and government regulations. The Quality System Manager will work with all leaders for ensuring a continued state of operational compliance to company expectations while promoting a strong quality culture across the organization.. Responsibilities. • Manages the Quality Systems Team including team members, responsibilities, and systems.. • Supports and collaborates with Quality Operations, Quality Compliance, and Quality Analytics teams. • Leads t... view job details
Description. Job Summary. Reporting to the VP of Quality and Compliance, the Manager of Quality Control is responsible for directing the Quality Control Laboratory and Monitoring Programs in order to ensure the overall quality of processes and products while maintaining the highest level of customer satisfaction. Job Responsibilities. • Ensure a high level of internal and external customer support. • Work closely with others in a team environment and act as an integral team member on multidisciplinary teams that provide. support for Manufacturing and Product Development activities. • Interpret... view job details
Description. Job Summary. This position is responsible for ensuring compliance of company policies and procedures for data integrity associated with automated and manual/paper-based GMP processes; for coordinating the control, storage, protection, retrieval and retention programs for all GMP controlled documents and electronic files. This position is also responsible for assuring that the site is in compliance with the specific US-GMP regulations, as it relates to data integrity. In addition, this position supports various administrative tasks for the Quality Assurance function, serving as a... view job details
Description. Prepares, reviews and submits high quality regulatory submissions to Regulatory Agencies (primarily FDA) within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions include IND's and NDA's (including 505(b)(2)), Annual Reports, amendments, Clinical Trial Applications, IND/NDA supplements, Orphan drug applications and Pediatric Study Plans. Provides input to established objectives and goals. Applies advanced knowledge of the pharmaceutical development cycle. Represents Regulatory Affairs within project teams and provides regulator... view job details