- Bayer (Myerstown, PA)
- …cGMPs) requirements. + Ensure processes are appropriately validated to conform to regulatory compliance ( FDA ) guidelines. Provides technical advice in the ... Technology + At least 6 years of experience in a pharmaceutical and FDA regulated packaging environment. + Experience defined as packaging development, including the… more
- 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… more
- Fujifilm (Montgomeryville, PA)
- …service. + 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** + High School Diploma or Equivalency is required. + Associate or bachelor's degree preferred, or post-high school professional training equivalent to the role. + Minimum 3 years'… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …returns 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
- 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:** + BA/BS or equivalent professional work experience + A minimum of (5+ years desired) full-time experience in PACS System Administration (FUJIFILM Synapse preferred) or equivalent… 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** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill,… more
- Globus Medical, Inc. (Audubon, PA)
- …DHRs for each project in the group according to Globus quality policy and all FDA and other regulatory bodies . Obtains market feedback from spine surgeons and ... other customers to determine functional and design specifications for new product development . Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure Compliance with applicable… 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. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** Experience + 4+ years previous… 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. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** Experience: + 8+ years of… more
- Globus Medical, Inc. (Audubon, PA)
- …or combination product development strongly preferred + Comprehensive knowledge of GMP, FDA , CBER, and CDRH regulatory requirements + Hands-on experience in ... technical reports, and ensures strict compliance with applicable quality and regulatory standards + Possesses in-depth knowledge of CBER (Center for Biologics… more