- Kedplasma (Pittston, PA)
- …Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... your job description as complete as possible. However, that in no way states or implies that these duties/responsibilities are the only duties you will be required to perform. The omission of specific duties/responsibilities does not exclude them from the… more
- Catalent Pharma Solutions (Malvern, PA)
- …programs associated with the position desired. + Good knowledge of the application of FDA cGMP's is required. + Good math skills preferred. + Individual may be ... required to sit, stand, walk regularly and occasionally lift up to 40 pounds. **Why You Should Join Catalent** + Competitive medical benefits and 401K + 152 hours of PTO + 8 Paid Holidays + Dynamic, fast-paced work environment + Opportunity to work on… more
- RELX INC (Horsham, PA)
- …strategy. This role ensures compliance with industry regulations (such as GxP and FDA 21 CFR Part 11), oversees daily operations, drives software development best ... practices, and manages global teams. You will be responsible for planning and executing product delivery while fostering innovation in cloud architecture, security, and software development. Conditions of Employment: + You must be a US citizen to apply for… more
- Globus Medical, Inc. (Audubon, PA)
- …respond and adapt to changing priorities + Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ... ISO 13485 and ISO 11607 **Education and Experience** + Bachelor's degree with 3 years of experience + Bachelor's degree in Mechanical Engineering, Packaging Engineering or any related technical discipline + Previous medical device packaging design experience… more
- ThermoFisher Scientific (Allentown, PA)
- …Chain Security Act), HDA (Healthcare Distribution Alliance) compliance (GS1 and FDA guideline support), and other serialized market regulations + Experience with ... Tracelink or equivalent EPCIS providers + Experience with serialization equipment/system setup and equipment validation + Experience with label design in Codesoft or equivalent software program **Knowledge, Skills, Abilities** + Proficient in process… more
- Charles River Laboratories (Wayne, PA)
- …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
- 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:** + Bachelor's degree in biomedical… more
- Nammo Defense Systems, Inc (Scranton, PA)
- …and time management skills * Familiar with Military Specifications or equivalent (pharmaceutical, FDA , etc.) * Familiar with ISO 9001-2015 * Ability to Read and ... Understand Drawing requirements * Ability to Understand and implement Gage design (GD&T) * Familiar with SPC * Attention to detail more
- BioLife Plasma Services (Camp Hill, PA)
- …Technician. Demonstrated understanding of quality assurance in an FDA -regulated environment. + Effective communication, organizational, and technical/problem-solving ... skills. + Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream… more
- NTT DATA North America (Pittsburgh, PA)
- …Knowledge of healthcare regulations and compliance standards (eg, HIPAA, FDA ). Education: Bachelor's degree in Business Administration, Healthcare Management, Life ... Sciences, or a related field. About NTT DATA: NTT DATA is a $30 billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long term… more