Program Coordinator

3 weeks ago


Shelbyville, United States Malone Workforce Solutions Full time

We are looking for a Data Compliance and Stability Program Coordinator to join the team This is a full-time, direct hire position that is 100% on-site in a manufacturing facility in Shelbyville, Kentucky.


Responsibilities - Stability:

  • Ensure compliance of the stability program to internal procedures and appropriate regulatory requirements.
  • Design and generate stability protocols and reports, review and evaluate stability data, write, and evaluate investigations, and address compliance challenges related to stability.
  • Collaborate with Quality partners to identify quality-critical tests and acceptance criteria to design appropriate stability studies.
  • Interface with Quality partners to ensure that the samples are analyzed, and the data is reported in a timely manner.
  • Interface with Operations and Supply Chain to ensure storage and packaging requirements of the stability protocol are achieved.
  • Analyze existing data and literature to generate stability reports.
  • Participate in the weekly Product Selection Committee meetings, and New Product Integration meetings.
  • Collaborate with Commercial and Quality teams on New Product offerings to understand customer and market requirements and provide shelf-life establishment recommendations based on the stability process and existing product knowledge.
  • Perform out-of-specification investigations on stability data per GGUI procedures.
  • Coordinate with 3rd party vendors to obtain necessary support for stability studies.
  • Assist in audit and compliance program to meet IPEC and applicable ISO laboratory accreditation requirements, including statistical analysis of data.

Responsibilities - Data:

  • Ensure compliance with industry standards (e.g., cGMP, 21 CFR Part 11, EXCiPACT).
  • Lead and participate in internal audits, gap analysis, and periodic review and risk assessments focused on data integrity.
  • Identify and address data integrity gaps and vulnerabilities, providing recommendations for remediation.
  • Participate in cross-functional projects aimed at enhancing data management systems and processes.
  • Collaborate with IT, Quality Assurance, and Manufacturing teams to ensure the integrity of electronic records and data management systems.
  • Drive the adoption of new technologies and methodologies to improve data integrity across the organization.
  • Prepare and present findings and reports to senior management.
  • Monitor and verify the implementation of new strategies related to data integrity.


Requirements:

  • Bachelor's degree in chemistry, biochemistry or related scientific field is required.
  • Minimum 5 years of analytical laboratory, quality assurance, or compliance experience in a GLP/GMP industry environment.
  • Knowledge of regulatory requirements related to data integrity e.g., cGMP, 21 CFR Part 11.
  • Experience with electronic data management systems and instrumentation used in pharmaceutical manufacturing is preferred.
  • Understanding of chemical stability principles, preferably ICH stability guidelines.
  • May require occasional travel to different manufacturing sites or for audit purposes.


Details:

  • This is a full-time, direct hire position that is 100% on-site in a manufacturing facility in Shelbyville, Kentucky.
  • Schedule: Monday – Friday, Days.
  • Pay: BOE
  • This is a W-2 position. No B2B/C2C; no sponsorship.


Malone is an Equal Opportunity Employer.


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