Program Coordinator
3 weeks ago
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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