Sr. Compliance Scientist
Sr. Compliance Scientist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Laboratory Applications and System Support
- Evaluate systems applications and processes to ensure controls are in place to maintain security and integrity of data including adequate audit trail is established for data traceability.
- Ensure updates to equipment methodologies and processes are performed under approved change controls; perform change control assessments per user requirements.
Investigation & Non-Conformance Support
- Participate in quality investigations to evaluate conformance to specifications company procedures and overall compliance to regulations.
- Ensure non-conformances are thoroughly investigated and appropriate corrective and preventive actions are implemented per established procedures and regulations.
- Ensure timely closure of Change Controls CAPAs and quality actions including effectiveness of corrective measures.
Document & Process Support
- Draft procedural documents to align processes across functions; develop and maintain local procedural documents in accordance with company and site policies and established regulations.
- Maintain processes and controls ensuring that performance and quality conform to established standards
- Ensure procedural documents are reviewed and updated periodically per established timelines.
Internal/External Inspections
- Assist in preparation for internal and external inspections and audit including compiling pre-requests.
Metrics Trends & Continuous Improvements
- Monitor and trend compliance metrics audit findings process indicators and compliance issues to improve quality systems and drive overall compliance.
- Inform/discuss with Compliance Lead potential risks and issues and/or opportunities for improvement and best practices to promote and strengthen commitment to compliance and safety.
- Participate in cross-functional team to ensure compliance measures are effectively implemented
- Support SME for all compliance related issues and in collaboration with quality team.
- Perform tasks in compliance with all local state and federal regulations and guidelines including but not limited to FDA EMA and OSHA; Comply with all company and site policies and procedures.
- This role will require 25% travel between client sites
Qualifications :
Minimum Requirements
- Completed Bachelors degree in chemistry biology biochemistry or other relevant scientific concentration
- 2 years of directly related compliance experience in the pharmaceutical industry
- Experience in Quality Assurance Quality Systems and/or New Product Development in a regulated environment
- Experience with writing procedural documents protocols reports
- Knowledge of current U.S. and EU cGMPs/regulatory standards
- Knowledge of 21 CFR/Part 11 Compliance regulations governing equipment validation and controls
Preferred Qualifications
- Knowledge of the overall drug development/manufacturing process is preferred
- Data Integrity Assessments Equipment Qualification & Controls
- Internal/External audits support
- Training Support
- Quality Systems & Application support CW/SUMMIT Trackwise tru Vault Biovia
Additional Information :
Position is full-time Monday-Friday generally 8 a.m. - 5 p.m. weekend work might be expected. Candidates currently living within a commutable distance of Malvern PA are encouraged to apply. This role will require 25% travel to the Spring House PA site.
Excellent full time benefits including comprehensive medical coverage dental and vision options
Life and disability insurance
401(k) with company match
- Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
