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Compliance Specialist

4 months ago

Rensselaer, United States Eurofins USA PSS Insourcing Solutions Full time

**Company Description**
The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

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 believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
- Develop a comprehensive set of quality metrics aligned with organizational goals and industry standards. This involves collaborating with stakeholders to identify key performance indications (KPIs) and defining measurable objectives.
- Collaborating with cross functional client Quality and other PSS site team.
- Collecting data from various process areas, defect reports and performance metrics. Analyze the data to identify trends, patterns, and areas of improvement.
- Generate regular investigation, training reports to provide visibility into quality performance. Manage quality improvement activities, meetings and other activities supporting the work of the departments.
- Presenting and Communicate quality related metrics, trends, and insights to stakeholders at various level of the organization. Present findings in meetings, reviews, and reports to facilitate informed decision making.
- Evaluate and managing resources and task
- understanding department needs to evaluate resources needed by implementing the Capacity model system and cross-functional training.
- Work in a GMP-regulated environment to provide and assist in the implementation of quality-related activities.
- Assist with other aspects of quality improvement including administrative and operational support as needed.
- Drive continuous improvement efforts through monitoring/evaluation of site systems & processes aligned with GMP and FDA requirements. To ensure adherence with quality standards and best practices.
- Evaluate the thoroughness and effectiveness of the training program. Foster a culture of quality awareness and continues improvement throughout the organization.
- Provide oversight of systems to ensure compliance with internal policies, procedures, and guidelines.

**QA Essential Duties and Responsibilities**:

- Applies GMP/GLP in all areas of responsibility, as appropriate
- Demonstrates and promotes the company's vision
- Regular attendance and punctuality
- Ensure that the quality policy program is understood, implemented, and maintained at all levels of the organization; identify, prevent, or correct any departures from the quality system
- Coordinate workflow and perform daily monitoring to meet TAT
- Perform and/or assign other duties as requested to ensure the smooth operations of department

**Qualifications** Education Requirements**:

- Bachelor’s degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering

**Basic Minimum Requirements**:

- 1+ years of related pharmaceutical experience
- Strong knowledge of global regulatory and cGMP requirements, industry best-practices
- Strong familiarity with production operations.
- Strong technical writing.

**Additional Information**
- 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
- Eligibility for potential yearly Bonus & Merit-Based Pay Increases
- Base compensation is $19-$27 per hour based on experience.

**Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.