- System One (East Windsor, NJ)
- …information to notify the FDA of illegitimate products. + Assist the Associate Manager of QA Compliance in notifying the FDA of illegitimate products within ... Products Responsibilities: + Under the oversight of the Associate Manager of Quality Assurance (QA) Compliance, this position will...system to notify the US Food and Drug Administration ( FDA ) of illegitimate products, as and when needed. +… more
- Pilgrim's (Greeley, CO)
- …in Project Management Systems such as SAP, Accolade, etc. + Good understanding of USDA, FDA guidelines with occasional support from manager . + Must be willing to ... or branded food shows with the support of their manager + Ideates customer menu solutions that are consumer...needs into selling strategies with the support of their manager . + Executes food production in accordance of Food… more
- Globus Medical, Inc. (Audubon, PA)
- …submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This position entails development of ... FDA submissions, requiring working knowledge of products under review...Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for… more
- Cardinal Health (Mansfield, MA)
- …analytical method transfer protocols following the regulatory requirements (ICH, USP and FDA ). + Perform investigations of Out of Specification (OOS) test results as ... needed follow FDA guidelines. + Maintain compliance with relevant regulatory requirements...the data by team members. + Work with lab manager and senior staff members of pharmaceutical analysis department,… more
- Lundbeck (Deerfield, IL)
- …managing end-to-end process of promotional material inventory, fulfillment, and compliance, FDA 2253 submissions and field operations day to day support. The ... role ensures timely and accurate submission of promotional materials to the FDA 's Office of Prescription Drug Promotion (OPDP). The specialist will also coordinate… more
- Boar's Head Brand/Frank Brunckhorst Co., LLC (Sarasota, FL)
- …executed as required by both internal quality programs/systems as well as required by FDA and USDA. + Lead the FSQ Team through the Export Product Commercialization ... New & Existing Local Purveyors (and their teams) in FDA compliance. + Oversee Quality Auditing programs including SQF...in the food industry; 5-10 years experience as a manager in Quality Assurance, R&D, Food Safety, or other… more
- Pilgrim's (Greeley, CO)
- …Systems and Recipe Development (eg, SAP). + Good understanding of USDA and/or FDA guidelines with occasional support from manager . + Proficient in Microsoft ... Excel, Outlook, Word, PowerPoint, and Microsoft TEAMS / Cisco Webex. + Ability to travel 30-40% of the time to plants and customers. + Can perform the functions of the job with or without a reasonable accommodation + As a salaried position with the company,… more
- Medtronic (Minneapolis, MN)
- …resolve potential regulatory issues and questions from regulatory agencies. + Prepare FDA , European, and Canadian submissions for product changes to ensure timely ... approval for market release. + Review significant regulatory issues with the manager as necessary, and resolve submission issues with engineering partners, geography… more
- Bristol Myers Squibb (Princeton, NJ)
- …BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances. **Responsibilities include:** + Provides regulatory advice, ... compliance of all promotions with approved labeling and /or FDA guidances + Ensure regulatory compliance with subpart E/H...+ US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to… more
- WuXi AppTec (Middletown, DE)
- …efficiently, safely, and maintained in compliance with **Good Manufacturing Practices (GMP), FDA , and other regulatory standards** . The ideal candidate will support ... the cGMP Maintenance & Controls Manager and the Utilities Superintendent to implement cGMP compliant...analysis, and oil sampling + Ensure compliance with **GMP, FDA , OSHA, and other regulatory requirements** for maintenance activities.… more
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