- Actalent (Paramus, NJ)
- …+ Review, understand, and audit clinical-related regulations and guidelines (eg, FDA regulations, GCP, etc.). + Collaborate with clinical sourcing, supplier quality, ... and clinical partnership to manage clinical vendors. + Support the preparation, coordination, and participation of regulatory agency inspections. + Participate in and support quality improvement projects. Essential Skills + 5+ years of pharmaceutical… more
- Aerotek (Goshen, IN)
- …**Additional Skills & Qualifications** + Experience working in a regimented FDA facility is beneficial. + Ability to work autonomously with self-motivation ... and accountability. **Why Work Here?** Enjoy comprehensive benefits including medical, dental, and vision insurance starting on day one. Benefit from a 401k with matching, generous PTO accrual, and significant discounts on products after six months. The… more
- Actalent (Kenosha, WI)
- …Inspect products for various quality issues and document findings per ISO and FDA requirements within the ERP system. + Perform part inspections and measure ... dimensions of incoming, in-process, first piece, and finished workpieces. + Utilize various precision measuring instruments, including optical comparators, CMM or vision machines, along with templates and fixtures. + Assist with Corrective and Preventive… more
- Fotona (Philadelphia, PA)
- …States, in accordance with Fotona-approved protocols and guidelines. + Strictly adhere to FDA clearances and compliance. + Successful completion of 6 to 8 trainings ... per month. + Act as a key point of contact for customers and colleagues on medical inquiries, product protocols, and clinical applications. + Contribute to creating a positive internal working environment and successful business relationships between Fotona… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …or equivalent experience in leading projects. + Knowledge of the FDA medical device quality system regulations and international quality system standards/regulations ... (eg ISO 9001, ISO 13485) as it relates to the design and continued support of BD products. + Can develop strategy, plan projects, and drive the completion of long-term goals and objectives. + Able to use judgement to influence within and across functions to… more
- Integer Holdings Corporation (Chaska, MN)
- …Environmental and Security Management Systems, US Food and Drug Administration ( FDA ) regulations, company policies and operating procedures, and other regulatory ... requirements. * Operates and sets up CNC shop equipment with minimal assistance. * Accountable for meeting cycle time and yield expectations. * Ability to simultaneously operate more than one machine as required. * Sharpens and changes tooling as needed to… more
- Astrix Technology (Piscataway, NJ)
- …projects to support product and process integrity. + Ensure ongoing compliance with FDA , EMA, ICH, and other global regulatory standards. + Provide leadership and ... mentorship to quality team members; foster collaboration across manufacturing, validation, and regulatory teams. + Support audits, inspections, and regulatory reviews, ensuring readiness and robust documentation. + Drive continuous improvement initiatives,… more
- Charles River Laboratories (Spencerville, OH)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- PACIV (Indianapolis, IN)
- …year of experience in pharmaceutical or medical device industries; knowledge of FDA regulations at plus + Familiarity with process instrumentation (level, flow, ... pressure, temperature sensors, valves, accessories) + Previous warehouse experience and ability to lift 75lbs or more + Willing to operate or be trained to use hand trucks and forklifts + Strong interpersonal, verbal, and presentation skills; team-oriented and… more
- Veterans Affairs, Veterans Health Administration (Brownsburg, IN)
- …needed. Research a. Participation in research activities must be in accordance with FDA guidelines and regulations and VHA policy. b. Coordinates the receipt and ... distribution of all drugs in an investigational and/or clinical evaluation status and maintains appropriate records regarding their use as applicable. c. Serves as primary investigator for pharmacy resident and/or student research projects as necessary. Work… more