Senior QC Chemist - Data Review Specialist

SUMMARY

Analytical Data Review, Peer Reviewer, and former bench chemist with over thirty years experience in GxP/GMP laboratories and quality control. Expert in instrumental operations and data management using analytical methods and techniques.

Analytical Chemistry:GC, HPLC, TOC

Protein chemistry including ELISA, CE, ICE, Degredents, PCR

R&D Technology Development

Fluent I MS Office

CDS, Chromeleon 7.2.8

Empower 3 and 5

ELN’s (electronic lab notebooks)

Sample Manager, LIMS

USP/NF Online

EP

EXPERIENCE

AQUESTIVE THERAPEUTICS

Senior QC Chemist Techincal Data Review

(10-23-04/2026)

Technical review of laboratory data, reports, validations, protocols, and logbooks according to In-house SOPs, USP and EP

Ensure data integrity of all reviewed data, in-process and finished drug product, drug substance, stability, and raw materials

Review deviations and laboratory investigations for in-process and finished drug product, drug substance and stability

Author, edit and review technical reports, protocols, specifications and SOPs

Data review in Chromeleon

Uses best practices and knowledge of internal or external business needs to improve products or services

Solves complex problems, takes a new perspective using existing solutions

Works independently and receives minimal guidance

Acts as a mentor and a resource for colleagues with less experience

Competent at risk mitigation for function

CATALENT, BLOOMINGTON IN

Senior QC Representative Data Review

(02/21-04/05/23)

Peer review of laboratory data, reports, ELN’s, and logbooks according to In-house SOPs, USP, EU, and JP

Ensure data integrity of all reviewed data, in-process and finished drug product, drug substance and stability

Review deviations and laboratory investigations for in-process and finished drug product, drug substance and stability

Data review in Empower and LIMS

Uses best practices and knowledge of internal or external business needs to improve products or services

Solves complex problems, takes a new perspective using existing solutions

Works independently and receives minimal guidance

Acts as a mentor and a resource for colleagues with less experience

Competent at risk mitigation for function

LANNETT COMPANY INC, SEYMOUR IN

Analytical Data Reviewer

(11/16-02/21)

Peer review of laboratory data, reports, notebooks, and logbooks according to In-house SOPs, USP, EU, and JP pharmacopia

Ensure data integrity of all reviewed data, finished product (release) and stability

Review deviations and laboratory investigations for finished product (release) and stability

Review cleaning validations for Analytical Services

Review Protocols from Tech Services

Review Method Transfers from Tech Services

Data review in Chromeleon, LIMS and Data Trending

Experience with CDS-LIMS Link

Drug Product and Stability Chemist

(05/14-11/16 )

Perform accurate and timely analysis of process verification, validation, in process and finished product release samples according to current analytical procedures, SOP's and specifications

Perform accurate and timely analysis of post-approval stability samples according to current analytical procedures, SOPs and stability protocols

Perform analytical method transfers with the Analytical Development Support group to QC

Perform laboratory equipment calibration

Provide well-written, accurate and timely analysis regarding laboratory investigations

Document all laboratory testing and maintain accurate and legible notebooks and records.

Peer review of data, reports and notebooks

Special projects or other tasks as deemed necessary based on individual's qualifications, business needs and QC Management's discretion

Assist in the evaluation and improvement of analytical procedures, SOP's and specifications

References available upon request

Northern Kentucky University, Highland Heights, Kentucky

Major: Bachelor of Science in Chemistry (12/02)

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