Quality Control Team Member

Mallory Clagg

Bailey, NC • 252-***-**** • **************@*****.*** • https://www.linkedin.com/in/mallory-clagg-3b252582/

EDUCATION

Campbell University, Buies Creek, NC August 2023

Bachelor of Science in Pharmaceutical Sciences

WORK EXPERIENCE

Quality Control Chemist I Purdue Pharma LP, Wilson, NC August 2023 – October 2024

Performed accurate routine and non-routine testing utilizing instrumental methods of analysis including HPLC, TLC, pH, UV-Vis, and UPLC.

Performed complex routine and non-routine Quality Control chemistry testing as required to meet departmental objectives and needed releases.

Generated and interpreted chromatography produced from HPLC and UPLC analysis for tests including dissolution, assay, content uniformity, and degradation.

Utilized Empower software for chromatography generation and interpretation.

Cross trained and capable of running multiple tests on multiple product families to meet departmental objectives and releases.

Performed confirmation testing for lab investigations as needed when OOT or OOS results were generated.

Created and monitored progress of lab investigations for OOT/OOS results in Veeva Vault and Trackwise.

Ensured all documentation met Good Documentation Practices while effectively utilizing ALCOA (attributable, legible, contemporaneous, original, and accurate) notation.

Assisted in the formal training of new analysts/lab personnel on topics such as GxP and safety.

Performed accurate peer review of prepared solutions and data to ensure compliance and accuracy throughout peer testing.

Intentionally followed all cGMP, FDA, and DEA regulations.

Prepared solutions and standards needed for testing on a regular basis, following current Standard Operating Procedures and Test Methods.

Ensured chemistry laboratory always followed FDA regulations.

Always maintained a clean and tidy workspace.

Created and followed goals and objectives, continually supporting Quality Control department goals and objectives.

Trailblazed the usage of new technology in the laboratory including Waters ARC HPLC systems and Waters Alliance iS HPLC systems.

Created and updated method sets, instrument methods, and processing methods in Empower projects relating to assigned testing.

Ensured Health and Safety standards are always followed.

Cleaned, maintained, and stored all lab equipment properly before, during and after usage.

Maintained the inventory of standards, reagents, and equipment needed in the laboratory.

Coordinated with colleagues to ensure a minimum of 16 batches of products were released every week.

Performed testing on approximately 16-24 batches of product every week.

INTERNSHIP EXPERIENCE

Pharmaceutical Technology Intern Purdue Pharma LP, Wilson, NC Summer 2022 and 2023

Led and executed a capstone project, under the direction of an appointed team member, to address a companywide issue regarding customer complaints of a specific product.

-Assisted department statistician with creating an effective design of experiments.

-Performed Reference Listed Drug tablet evaluation of physical properties for comparison data.

-Utilized established scale up calculations to determine amounts of material needed for each batch of product.

-Successfully dispensed material per established master batch record for specific product.

-Successfully assembled a Comil and Blend Master blender with an I-Bar for blending.

-Blended dispensed material per established master batch record for specific product.

-Performed compression profile curve to establish what force yielded target tablet hardness and compressed final blend at appropriate force.

-Tooled, operated, and disassembled 16-station Kilian PressIMA with appropriate tooling.

-Create master batch record, mirroring established batch record, for small scale batch sizes used during project with developmental purposes.

-Followed company’s internal procedure for requesting and properly storing project materials.

-Operated a digital caliper, floor balance, table balance, friabilator, and hardness tester when testing Reference Listed Drug and developmental tablets.

-Assisted appointed team member with the creation of tables, charts, and protocols submitted for the final report discussing all findings from the project.

-Created a presentation based on data driven results and presented to multiple departments within the company to showcase current progress made on the efforts to reduce customer complaints.

-Successfully reduced customer complaints each quarter by approximately 95% in the year following project completion.

Assisted senior team member with cleaning validation, using the swabbing technique, per appropriate Standard Operating Procedures.

Exposed to high level diversion control operations within a fully narcotic producing company.

Utilized effective attributable, legible, contemporaneous, original, and accurate notation during projects and while working in manufacturing.

Observed and practiced impeccable Good Manufacturing Practice protocols through the company site.

Observed other aspects of the company, such as, dispensing, encapsulation, validation, cleaning, testing, and packaging.

Observed other responsibilities including investigations and CAPA (Corrective Action Preventative Action) creation and implementation.

Observed large scale equipment in use such as Kilian Press, Fette Tablet Press, Encapsulator, and Roller Compactor (with and without vacuum) based on current product parameters.

Observed company and employee’s response to an intense Food and Drug Administration audit.

SKILLS

Analytical Techniques/Equipment

HPLC

TLC

UV-Vis

pH Analysis

Dissolution Apparatus

Disintegration Apparatus

Software

LIMS

Empower

Trackwise

Veeva Vault

Regulatory Compliance

cGMP

GxP

FDA

DEA

ALCOA

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