Tammy Rosado
Manufacturing Compliance Program Manager
- Role
- Manufacturing Compliance Program Manager at KBI Biopharma
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Tammy Rosado
Accomplished Quality Assurance professional with 20+ years of experience in both the GMP Biotechnology and Pharmaceutical industry. Biotechnology experience includes: Quality Control and Quality Assurance support for both commercial and clinical products.Specialties include: Technical writing for Investigations/CAPA’s, Equipment/ CSV Validation Approval, QA Stability Management, Periodic Reviews for Equipment, QC Sample Management, QA Change Control Management, Annual Quality Report (APQR), Product Quality Complaints (PQC’s), Vendor Management,Batch Record Review, Product Disposition
Experience
Manufacturing Compliance Program Manager
Sep 2021 — Present · Raleigh-Durham-Chapel Hill, NC, US
1) Monitors, communicates and facilitates compliance timelines for the Manufacturing Department-Corrective Action/Preventive Action progress, Extensions/Interim reports and closure -CAPA Effectiveness Check closure -Change Control progress for deliverables, extensions and closure -Change Control Effectiveness Check Closures -Periodic Review for SOP’s -Closure of Calibration Alert Notifications (CAN’s)-Change Control Closure to meet QA disposition timelines 2) Collaborate with Quality Assurance and other departments to accomplish compliance and closure timelines. 3) Organize Collaboration meetings to resolve or expedite Quality events to ensure compliance. 4) Complie and track monthly manufacturing room audits for departments: Upstream, Downstream and Support groups
Education
BS Biology - East Carolina University
BS, Biology
1992 — 1997
Skills
- Microbiology
- Standard Operating Procedure (Sop)
- Software Documentation
- U.s. Food and Drug Administration (Fda)
- Capa
- Chromatography
- Laboratory
- Gcp
- Biopharmaceuticals
- Testing
- Glp
- Quality Assurance
- CRO
- Corrective and Preventive Action (Capa)
- 21 Cfr Part 11
- Clinical Trials
- Technology Transfer
- Quality Control
- Gmp
- Validation
- Lims
- Hplc
- Quality System
- Aseptic Technique
- Biotechnology
- Change Control
- Pharmaceutical Industry
- Sop
- Fda
- Quality Auditing
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