Connor Harkins
Quality Specialist
Macungie,PA
Summary
Knowledgeable Quality Professional with history of ensuring quality standards in the pharmaceutical and medical device industry. Successfully led initiatives to improve product consistency and compliance with regulations. Proven ability in problem-solving and implementing quality control processes.
Overview
7
7
years of professional experience
Work History
Quality Specialist
GSK
12.2023 - 12.2024
- Collaborates with cross functional teams to fully comprehend clinical study release requirements and the regulatory obligations.
- Support clinical studies for the US and EU markets, respond to regulatory inquiries.
- Ensures product batches that have not met the prescribed in-process and finished product specifications and regulatory requirements are dispositioned to be quarantined or rejected, to prohibit use or release by patients.
- Ensure redaction of study information on clinical records, ensuring remain blinded.
Quality Specialist
Verista
09.2022 - 12.2023
- Manage client projects, work with stakeholders to gather document parameters for requirements.
- Utilize QMS systems to accomplish project goals: Kneat, Sharepoint, Veevavault. Act as author and initiator for clinical projects.
- Author change control processes, IQ, and PQ, per client requirements.
- Interview personnel involved in deviations, author deviations for breaches in product quality.
- Experience in GCP, reviewed sensitive clinical documentation for Oncology products.
Change Control Specialist
Merck
06.2021 - 09.2022
- Manage vendor project lifecycle, from end to end. Qualify new material and MOC (Material of construction).
- Work within site systems for updates and have interaction with clients for impact.
- Determine company impact and scope for material changes to manufacturing process flow.
- Author technical papers justifying expiry extensions for raw material expiry dates beyond manufacturer shelf life.
- Utilize the following QMS systems to manage change control: SAP, Trackwise, Midas, IPI.
- Revise and update documentation: SOPs, WI, and supplier quality agreements.
Quality Specialist
Lubrizol
01.2021 - 06.2021
- Revise and update SOP according to the change control process.
- Audit vendors to ensure compliance to the supplier quality agreement, qualify new vendor material.
- Ensure manufacturing equipment is clean and calibrated, approve line clearance for manufacturing.
- Sample High potent APIs for formulation, using cleanroom/lab equipment and processes.
- Manage change controls, review change plans and ensure they meet quality standards.
- Review environmental data (EM) in cleanrooms, ensuring any excursions are reviewed against specification.
Quality Specialist
Merck
08.2019 - 12.2020
- Approve and distribute global documents to various systems such as regulated content repositories and learning management systems (track wise, MIDAS, SAP).
- Revise and update SOPs, lead processes involving relevant SMEs and stakeholders. Create training documentation to keep other business functions in compliance with medical affairs guidelines.
- Coordinate with countries to ensure local documentation meets global standards.
- Act as point of contact among company business units for GMA.
- Manage group's RRS schedule, renewing documents and retiring documents as needed.
Quality Analyst
Astrazeneca
11.2018 - 08.2019
- Provide quality oversight for defects. Ensure yield meets specification.
- Review of product yields, reject types, and in-process control testing results.
- Compile technical reports for cross functional teams at vendors and Astrazeneca.
- Utilized process knowledge of contract packaging as it relates to FDA and cGMP guidelines to ensure compliance.
- Utilize Master Data Management to track Quality KPI to ensure product consistency.
Quality Specialist
Johnson & Johnson
01.2018 - 11.2018
- Responsible for the creation and distribution of Packaging Documentation to external manufacturing.
- Final approver for consumer drug labels, ensuring regulatory requirements are met before distribution.
- Utilized Mercury SAP for BOM approval and release. Trained in QA SAP modules.
- Identify, report and seek correction (CAPA) for deviations and Non-conformance. Notify other functional areas of noncompliance.
Education
Bachelor of Science - Psychology
DeSales University
Center Valley, United StatesSkills And Certifications - Skills
- Technical writing
- Documentation
- Clinical Trial Management
- GCP
- GMP
- GVP
- Medical Affairs
- Regulatory Affairs
- Veeva Vault
- Tracelink
- Trackwise
- Supplier Management
- Material Qualification
- Adverse Event Reporting
- Chemistry, Manufacturing, Controls
- Computer System Validation
- CAPA
- SAP
- Postmarket Surveillance
Timeline
Quality Specialist
GSK
12.2023 - 12.2024
Quality Specialist
Verista
09.2022 - 12.2023
Change Control Specialist
Merck
06.2021 - 09.2022
Quality Specialist
Lubrizol
01.2021 - 06.2021
Quality Specialist
Merck
08.2019 - 12.2020
Quality Analyst
Astrazeneca
11.2018 - 08.2019
Quality Specialist
Johnson & Johnson
01.2018 - 11.2018
Bachelor of Science - Psychology
DeSales University
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