Sr. Compliance Scientist

Eurofins; Malvern (Chester County); On-site; USD 65,000 - 85,000; Full time

Job summary

A leading company in life sciences, Eurofins is seeking a Laboratory Applications and System Support professional in Malvern, PA. The role includes evaluating systems for data integrity, participating in compliance investigations, and supporting procedural documentation. This full-time position offers extensive benefits and requires some travel between client sites.

Benefits

Comprehensive medical coverage

Dental and vision options

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Qualifications

• 2 years of related compliance experience in the pharmaceutical industry required.
• Knowledge of U.S. and EU cGMP’s/regulatory standards needed.
• Experience in writing procedural documents and protocols necessary.

Responsibilities

• Evaluate systems and applications for data integrity and compliance.
• Participate in quality investigations and document corrective actions.
• Support compliance measures and prepare for internal/external inspections.

Skills

Quality Assurance

Compliance

Document Writing

Data Integrity Assessments

Education

Bachelor's degree in chemistry, biology, biochemistry or relevant scientific concentration

Tools

CW/SUMMIT

Trackwise

truVault

Biovia

Job description

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Laboratory Applications and System Support

• • Evaluatesystems, 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

• • Participatein quality investigations to evaluate conformance to specifications, company procedures, and overall compliance to regulations.
  • Ensurenon-conformances are thoroughly investigated and appropriate corrective and preventive actions are implemented per established procedures and regulations.
  • Ensuretimely closure of Change Controls, CAPAs and quality actions, including effectiveness of corrective measures.

Document & Process Support

• • Draftprocedural documents to align processes across functions; developand maintainlocal procedural documents in accordance with company and site policies and established regulations.
  • Maintainprocesses and controls ensuring that performance and quality conform to established standards
  • Ensureprocedural documents are reviewed and updated periodically per established timelines.

Internal/External Inspections

• • Assistin preparation for internal and external inspections and audit, including compiling pre-requests.

Metrics, Trends, & Continuous Improvements

• • Monitor and trendcompliance 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.
  • Participatein cross-functional team to ensure compliance measures are effectively implemented
  • SupportSME 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 cGMP’s/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, PAare 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.