Doreen Stickney
- Role
- Quality Assurance Manager at Sunovion Pharmaceuticals
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Doreen Stickney
A member of the AstraZeneca Global Aseptic Forum Panel, who provides strategic…
Experience
Quality Assurance Manager
Feb 2017 — Present
Manager Quality Assurance, 2017 to Present Provide QA GMP quality support for clinical programs, commercial drug, and combination product: • Responsible for Master Batch Record review and approval (API, CTM, clinical packaging, drug product, combination product, commercial packaging, and serialization) • Responsible for executed Batch Record review and approval • Responsible for resolving quality events and writing quality investigations • Responsible for implementation of any appropriate CAPAs • Responsible for batch release and disposition for clinical use • Responsible for evaluating CTM temperature excursions Responsible for Commercial release: Managed time out of refrigeration for a cold chain product during production through distribution. • Includes commercial temperature excursion evaluation. Experienced in Supplier relations: • Set up QA relationships with new and existing Suppliers • Developed cadence and mutual expectations. Experience with Cross functional teams: • Change Controls requiring revalidation • Sterility Assurance Validation • Bringing new Suppliers, manufacturing lines and processes online
Education
Anna Maria College
Phlebotomy
Villanova University Department of Education and Counseling
Six Sigma Green Belt
2016 — 2016
Fitchburg State University
BS Biology/Chemistry
Worcester Polytechnic Institute
Fundamentals of Bio Manufacturing Certificate
2015 — 2015
Skills
- Sterilization
- Standard Operating Procedure (Sop)
- Validation
- Chromatography
- V&V
- Sop
- Capa
- Formulation
- Hplc
- Gamp
- Quality Auditing
- Vaccines
- Pharmaceutical Manufacturing
- Drug Development
- Gmp
- Biotechnology
- Quality System
- Trackwise
- Good Laboratory Practice (Glp)
- 21 Cfr Part 11
- U.s. Title 21 Cfr Part 11 Regulation
- Quality Assurance
- Change Control
- Aseptic Processing
- Medical Devices
- Analytical Chemistry
- U.s. Food and Drug Administration (Fda)
- Computer System Validation
- Cross-Functional Team Leadership
- Pharmaceutical Industry
- Gxp
- Fda Gmp
- Lims
- Cleaning Validation
- Regulatory Requirements
- Biopharmaceuticals
- Lifesciences
- Deviations
- Regulatory Affairs
- Corrective and Preventive Action (Capa)
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