1. Job Title: Professional - Drug Safety Associate
Job Description: Primary purpose and function of this position: Responsible for comprehensive adverse event report case management, maintaining compliance with local SOPs and worldwide regulatory timelines.
Major duties and responsibilities that are critical and necessary, and that must be done to achieve this position's overall objective.
Performs all aspects of data entry including coding of events, determination of labeling (with assistance from medical review if needed), determining reportability and completing cases within required timelines.
Manages telephone reports from consumers, marketing partners, healthcare professionals and handles necessary follow-up. Assist with Preparation of periodic safety reports. Responsible for the independent preparation of expedited case submissions to the FDA.
Keeps current with regulatory and labeling updates. Other duties and responsibilities as assigned.
Travel: limited local travel
2. Job Title: Quality Specialist
Duties Responsible for auditing all records associated with Manufacturi Reviews manufacturing formulation batch production records to ensure compliance with internal specifications and cGMP.s. Assures documentation is in compliance with cGMP regulations and ISO9001 guidelines. Compiles history records for medical lots in preparation for product release. Drafts and reviews specifications and SOP.s. Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data. Work is closely supervised. Follows standard practices to obtain solutions. Contributes to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Contacts are primarily with immediate supervisor and other personnel in the section or group.
Skills MUST HAVE strong experience in performing quality reviews of manufacturing batch records and release of product in a pharmaceutical/medical device industry
Keywords
Education Bachelor.s degree and 0 - 2 years experience
3. Job Title: Compliance Specialist Associate
Duties The compliance specialist will evaluate temperature excursions during distribution. The compliance specialist will be trained on the complaint management process. They will follow standard operating procedures in performing documentation review and tasks.The compliance specialist will provide product disposition memos using a template.
They will perform data entry and record review in the complaint management software (Catsweb). Work will be closely supervised.
Skills The compliance specialist should have a basic understanding of quality assurance systems and be familiar with current Good Manufacturing Practices. Familiarity with current Good Distribution Practices is desirable but not necessary.
Candidate must have the ability to work in a fast paced team environment. Candidate must be organized and have the ability to multi-task with attention to detail.
Familiarity with Catsweb (complaint management software) and Trackwise (quality management system software) is desired but willing to train a fast learner.
Education Bachelor's degree and 0 - 2 years
4. Job Title: Quality Specialist
Duties Responsible for auditing all records associated with Manufacturi Reviews manufacturing formulation batch production records to ensure compliance with internal specifications and cGMP.s. Assures documentation is in compliance with cGMP regulations and ISO9001 guidelines. Compiles history records for medical lots in preparation for product release. Drafts and reviews specifications and SOP.s. Monitors and trends batch record errors and provides Quality Assurance management with quality indicator data. Work is closely supervised. Follows standard practices to obtain solutions. Contributes to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Contacts are primarily with immediate supervisor and other personnel in the section or group.
Skills MUST HAVE strong experience in performing quality reviews of manufacturing batch records and release of product in a pharmaceutical/medical device industry.