- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …to ensure compliance with pharmaceutical traceability and labeling standards + Maintain FDA and DEA regulatory compliance by ensuring cleanroom integrity and proper ... handling of temperature-sensitive and controlled substances. + Prepare orders for shipment by palletizing and staging them according to destination zones and transportation requirements + Participate in cycle counts, audits, and ongoing distribution process… more
- West Pharmaceutical Services (Williamsport, PA)
- …in the **medical device industry** with a strong understanding of regulatory requirements ( FDA , ISO 13485, GMP) would be an advantage. + Expertise in scientific ... molding, process validation, and statistical process control. + Knowledge of manufacturing processes, workflows, production equipment and industrial techniques. + Knowledge of Good Manufacturing Practices (GMP) requirements would be an advantage. + Knowledge… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …adhering to company policies, procedures, and documentation requirements + Maintain FDA and DEA regulatory compliance by ensuring cleanroom integrity and proper ... handling of temperature-sensitive and controlled substances + Ensure all inbound products are correctly put-away to bin location for storage, replenishment and picking functions + Participate in cycle counts, audits, and ongoing distribution process… more
- Deloitte (Pittsburgh, PA)
- …familiarity with ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, ... NDA, BLA, MAA) + 1+ years experience leading, managing and delivering complex engagements with resources in multiple locations + Bachelor's Degree + Ability to travel up to 50% on average, based on the work you do and the clients and industries/sectors you… more
- PCI Pharma Services (Philadelphia, PA)
- …eligible to apply for open positions._** **Preferred:** + Strong knowledge of cGMP, FDA regulations, and validation principles. + Experience in a CDMO environment. + ... Ability to effectively present information to various people as the job requires. + Ability to show success in managing employees. + Ability to set and achieve challenging goals. + Ability to display a willingness to make decisions. + Proven experience in… more
- University of Pennsylvania (Philadelphia, PA)
- …resource and financial implications. + Understanding and keeping current with FDA and Medicare regulations applicable to clinical trials. + Understanding interaction ... of Medicare regulations and/or third-party insurance to develop clinical trial budgets. + Preparing financial analyses, as necessary, and serving as a resource to clinical investigators. + Working with the Managers of Clinical Research Billing and Clinical… more
- PCI Pharma Services (Philadelphia, PA)
- …and installation to meet customer requirements. + Assure compliance to GMP's, SOP's, FDA , DEA and OSHA rules and regulations. + Interact with all customers and ... management to achieve objectives. + Able to balance multiple issues simultaneously in a fast pace environment + Coordinate resources with requirements that are driven by the production schedule. + Instruct mechanics on their job assignments and their… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. **Qualifications:** Baseline Qualifications: + Bachelor's Degree, Trade School Certification (Industry related), or Industry Experience Equivalent + One or more industry-specific certifications in relevant… more
- Biomat USA, Inc. (Williamsport, PA)
- …projects are in compliance with local/state/federal codes and regulations, including OSHA, FDA , Fire, Building/Safety, etc. + Track and evaluate critical data to ... recommend continuous process improvement. + Maintain communication between department management and all cross-functional teams. + Manage multiple local contractors to complete work in donor centers across the company. + Authorize and negotiate work… more
- System One (Pittsburgh, PA)
- …Good Clinical Practice (GCP) guidelines defined by the International Committee on Harmonization, FDA , NCI/NIH, OHRP, and the Office of Civil Rights, and according to ... state and institutional regulations. + Able to apply broad technical, clinical/professional knowledge and significant job-related experience. + Excellent writing capabilities, including the ability to write reports and business correspondence. + Experience of… more