QA Specialist - Compliance
Eurofins

Malvern, Pennsylvania

This job has expired.



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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins 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. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers 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 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

  • Laboratory Applications and System Support
    • Evaluates 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
    • Participates in quality investigations to evaluate conformance to specifications, company procedures, and overall compliance to regulations.
    • Ensures non-conformances are thoroughly investigated and appropriate corrective and preventive actions are implemented per established procedures and regulations
    • Ensures timely closure of Change Controls, CAPAs and quality actions, including effectiveness of corrective measures.
  • Document & Process Support
    • Drafts procedural documents to align processes across functions; Develops and maintains local procedural documents in accordance with company and site policies and established regulations
    • Maintains processes and controls ensuring that performance and quality conform to established standards
    • Ensures procedural documents are reviewed and updated periodically per established timelines
  • Internal/External Inspections
    • Assists in preparation for internal and external inspections and audit, including compiling pre-requests
  • Metrics, Trends, & Continuous Improvements
    • Monitors and trends compliance metrics, audit findings, process indicators, and compliance issues to improve quality systems and drive overall compliance.
    • Informs/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.
  • Participates in cross-functional team to ensure compliance measures are effectively implemented
  • Supports 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; Complies with all company and site policies and procedures.
  • This role will require 25% travel to client sites

Qualifications
  • Bachelor's degree in chemistry, biology, biochemistry or other relevant scientific field with at least 5 years of regulated industry experience OR Master's degree in chemistry, biology, biochemistry or other relevant scientific field with at least 2 years of regulated industry experience is required
  • At least 2 years of GMP experience within clinical/commercial research and development and/or quality assurance is required
  • Experience in Quality Assurance, Quality Systems, and/or New Product Development in a regulated environment is required
  • Experience with writing procedural documents, protocols, reports is required
  • Knowledge of current U.S. and EU cGMP's/regulatory standards is required
  • Knowledge of 21 CFR/Part 11 Compliance regulations governing equipment validation and controls
  • 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 9:00am - 5:00pm. Candidates currently living within a commutable distance of Malvern, PAare encouraged to apply.
  • 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 is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.


This job has expired.

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