- Brenntag AG (Reading, PA)
- …and quality manuals. + Hands-on expertise with regulatory frameworks and standards such as FDA , EMA, ICH guidelines, GMP, ISO 9001, SQF, GMP+, BRC, etc. + In-depth ... knowledge of designing, implementing, and maintaining quality management systems tailored to highly regulated industries. + Expertise in planning, executing, and following up on comprehensive internal auditing programs. + Experience in coordinating and… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the US At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.ZOLL has been… more
- UPMC (Pittsburgh, PA)
- …+ Maintain laboratory Drug Master Files that will be submitted to the FDA . Assist to create and maintain the Laboratory Disaster Plan. Monitor annual laboratory ... safety inspections. Monitor hazardous and biological waste disposal. + Participates as appropriate on various committees related to safety and regulatory compliance as requested and needed. + Research regulatory requirements, prepare and submit reports, and… more
- Takeda Pharmaceuticals (Exton, PA)
- …different computer systems; knowledge and understanding of global regulations ( FDA 21CFR Part 11(210/211), 21CFR820, ISO-15489,ANNEX 11, etc.) related to ... pharmaceutical and healthcare industry; Physical and Electronic Data Archival and Retrieval knowledge utilizing Microfocus Content Manager, Control Point, Structured Data Manager, IM Connect, FileBridge, Policy Center systems; project management experience in… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of ... global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem solving skills. Demonstrated project management skills. Ability to interact with regulatory officials. Ability to evaluate complex issues and meet… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the US At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.ZOLL has been… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the US At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. ZOLL has been… more
- Merck (West Point, PA)
- …regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies ( FDA , EMA, JNDA, TGA). + **Leadership:** Establish, manage and support CMC ... teams, and align resources to deliver on priorities. Manage and mentor a team of scientists specializing in biologics commercialization, serving as the scientific/technical mentor for junior staff. Action-oriented, mindset for creativity; ability to take… more
- Sumitomo Pharma (Harrisburg, PA)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... marketed products. The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our… more
- Conagra (Milton, PA)
- …+ Develop the plant's health and safety programs in compliance with OSHA, FDA , USDA, and corporate standards. + Lead incident investigations and root cause analysis ... and recommend corrective actions to prevent recurrence. + Conduct safety audits, risk assessments, job hazard analyses (JHAs), and ergonomic evaluations. + Manager Worker's Compensation claims and track injury and illness statistics to help identify safety… more