Krystine Szczepanski
Principal Quality Assurance Professional at Abbott Hematology
- Role
- Principal Quality Assurance Professional at Abbott
- Location
- Santa Clara, CA, US
- LinkedIn followers
- 500 followers
About Krystine Szczepanski
Experienced Senior Compliance Analyst with a strong background in FDA regulations in…
Experience
Principal Quality Assurance Professional
Nov 2010 — Present · Santa Clara, CA, US
Responsible for drafting, submitting, organizing and maintaining records and reports for all site quality communications (risk evaluations process outputs) and field actions (device correction/recall activities), ensuring regulatory and site requirements are being met, and driven to completion. Obtains approved documents for submission, including but not limited to: quality directives, customer letter(s) and replies, complaint records, regulatory records (sections A and B), risk evaluations, and product distribution lists. Acts as the interface with the global commercial quality organization to obtain information regarding the effectiveness of the field actions and communicate with the Division Field Action Coordinator on status of open Field Actions at the site. Communicates with the global service and support organization regarding the timeliness of completion of the TSBs/ISAs related to Field Actions. Acts as the primary site contact regarding field actions, including, submitting information and updates to external regulatory bodies. Responsible for reporting appropriate quality communication and field action metrics to the site for review. Reviews and approves complaints in accordance with procedures and communicates any changes and edits to the complaint investigators in a timely manner. Ensures compliance with regulations, standards, and procedures that apply to complaint evaluations and medical device reports. Provide internal and external audit support.
Education
University of California, Davis
Zoology
1985 — 1990
Skills
- Compliance
- Elisa
- Gxp
- Pharmacology
- Biotechnology
- 21 Cfr Part 11
- Glp
- Clinical Development
- Lifesciences
- Inspection
- Laboratory
- Drug Development
- Gcp
- In Vitro
- Quality Assurance
- Gmp
- In Vivo
- Protocol
- Pharmaceutical Industry
- Sop
- Fda
- Drug Discovery
- Life Sciences
- Cgmp
- Research
- Molecular Biology
- Good Laboratory Practice (Glp)
- Medical Devices
- Capa
- Animal Models
- U.s. Food and Drug Administration (Fda)
- Pharmaceuticals
- Ind
- Standard Operating Procedure (Sop)
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