Cleta Davis
Quality Assurance Professional in Pharmaceutical /Biotechnology: Investigations (Laboratory and Manufacturing).Quality Audits in Pharmaceutical/Biotechnology
- Role
- Quality Engineer at 辉瑞
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Cleta Davis
Experienced in both the biotechnology and pharmaceutical industry. ICH, GMP, GLP, GCP, Reviewer, approver and driver of Quality Investigations.ASQ CQA (Certified Quality Auditor)
Experience
Quality Engineer
Jan 2012 — Present · Rocky Mount, NC, US
Quality Investigation Approver* Provided QA review and oversight for investigations, OOS, deviation, CAPA.*Reviewed and approved investigations of the laboratory, supplier and manufacturing areas.*Meet with investigators SMEs to discuss, strategize and determine root cause.*Ensure true root cause is determined and the appropriate CAPAs are implemented.Quality Auditor* Conducted audits to assess compliance, with regulations, guidelines, SOPs, and test methods. Periodic monitoring and verification of operations to ensure compliance to written procedures and/or regulatory requirement (Supplier Quality, Laboratories and Manufacturing)* Developed, implemented, maintained internal quality systems, procedures, and practices.* A resource and a go to person for other individuals from quality and the laboratory.(Supplier Quality, Laboratory and Manufacturing) Executed and provided excellent customer service to the company quality unit. Provided QA review of cGMP documentation (item specs, sop’s, batch records and STM’s. Making critical judgments and advising on observations during reviews of documents and discussions) Supported effective, timely, and efficient oversight of the compliance of internal laboratories with the requirements of the US and EU standards.* Evaluated laboratory data results and verified the accuracy of raw data to ensure compliance to procedures, acceptance criteria, and regulatory requirements and a thorough investigation of anomaly events. Provided QA review and release of incoming raw material.* Demonstrated a good degree of initiative to resolve problems, discuss and research actions to be taken before finalizing a resolution.
Education
Purdue Global
Master of Business Administration - MBA
Wayne State University
Bachelor, Chemistry
Skills
- Hplc
- Validation
- Quality Assurance
- Quality System
- V&V
- Lyophilization
- Aseptic Technique
- Ftir
- Technology Transfer
- Protein Chemistry
- Chromatography
- Pharmaceutical Industry
- Sop
- Quality Auditing
- Glp
- Chemistry
- Uv/Vis
- Biotechnology
- Capa
- Quality Control
- Gmp
- Biochemistry
- Gas Chromatography
- Uv
- Laboratory
- Biopharmaceuticals
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