- Berry Global (Brookville, PA)
- …for Team Amcor, visit www.amcor.com | LinkedIn | YouTube **Responsibilities** The Quality Engineer is responsible for implementation and enforcement of Quality ... Complaint Investigations & Responses in the Brookville, PA plant. Supports the Quality Manager to service customers and internal departments to maintain quality… more
- Sanofi Group (Swiftwater, PA)
- **Job title:** Manager Quality Validation **Location:** Swiftwater, PA **About the job** We deliver 4.3 billion healthcare solutions to people every year, thanks to ... get started? **Main Responsibilities:** + This position is responsible for providing Quality & Compliance oversight to site validation projects related to Drug… more
- Teleflex (Wyomissing, PA)
- …the ongoing lifecycle management of vascular access devices, ensuring product quality , regulatory compliance, and manufacturing efficiency. This role focuses ... Apply engineering principles to evaluate product design changes, ensuring compliance with regulatory and quality standards. * Contribute to design verification… more
- Sumitomo Pharma (Harrisburg, PA)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... teams. Regulatory Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions, clinical study reports, and… more
- Globus Medical, Inc. (Audubon, PA)
- …to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Designs and develops ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...and market plans + Assists in the writing of regulatory applications to the FDA and other… more
- Globus Medical, Inc. (Audubon, PA)
- …ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Perform design ... for rapid prototyping and evaluation. + Assist in writing regulatory applications to the FDA and other...to maintain compliance and product performance. + Collaborate with Quality , Regulatory , Manufacturing, and Supply Chain teams… more
- Kelly Services (Malvern, PA)
- …optimization and revalidation efforts. + Serve as a SME during internal and external regulatory audits including FDA , EMA . + Extract process data from SCADA ... Malvern, PA. + Work as primary investigator / Specialist to ensure consistent quality standards are maintained. + Collaborate with QA to initiate, author and drive… more
- Globus Medical, Inc. (Audubon, PA)
- …to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Design and develop ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...and market plans + Assist in the writing of regulatory applications to the FDA and other… more
- Sanofi Group (Swiftwater, PA)
- …possible. Ready to get started? **Main Responsibilities:** + Develop CMC regulatory strategies and assess associated risks for development projects and/or registered ... products (new products or marketed products) in collaboration with all Global Regulatory Affairs entities. + Participate in Change Control assessment. + Guarantee… more
- Sanofi Group (Swiftwater, PA)
- …for ensuring all Computerized Systems Validation (CSV) lifecycle activities meet Sanofi's quality requirements and fulfil regulatory expectations. + Design and ... are released for GMP use. + Provide support during regulatory inspections and site audits as quality ...and soft skills: + Sound knowledge and understanding of regulatory (including FDA 21 CFR Part 11,… more