- Actalent (Boston, MA)
- Job Title: QMS Specialist (25/hrs. per week) We are seeking a highly skilled QMS Specialist with experience in a GMP-regulated environment, ideally ... regulations for GMP compliance is essential. Responsibilities + Assess current QMS processes, identify areas for improvement, and implement effective solutions to… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated **Senior Validation Specialist - CSV** to ensure compliance of computerized systems with regulatory requirements in ... GAMP 5, and Annex 11. **As a Senior Validation Specialist , a typical day might include:** + Planning and...facility; GMP experience is required. Experience with ERP, LIMS, QMS and other GxP-regulated computerized systems and analytical instruments… more
- Medtronic (Mansfield, MA)
- …world. **A Day in the Life** We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute Care and Monitoring (ACM). In this ... standards (eg, ISO 13485), and experience with Quality Management Systems ( QMS ) + Technical Writing + International medical device regulatory submission/approval… more