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Quality Assurance Technician

Pearl River, New York

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    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

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"One of the best things about Sanofi Genzyme is the consistently fun and dynamic work environment that I get to be a part of."

Kristin Ouimet Regional Business Manager

"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."

Shannon Resetich US Head Rare Diseases & Blood Disorders

"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."

Mouhamed Gueye US Head Medical Rare Blood Disorders

Responsibilities

MISSION:

Responsible for routine shop floor compliance with applicable regulatory requirements by conducting audits, data and documentation reviews and analysis and other such duties and responsibilities as may be reasonably assigned to you.

All employees are responsible for training on, understanding, and following documented procedures which apply to their departments that support the Quality System.

KEY ACCOUNTABILITIES:

  • Review of shop floor documentation (batch records, Logbooks etc) for completeness and compliance

  • Assistance with audits (internal and external), which may require occasional overnight travel

  • Participation in the management of Quality Systems (Change Control and Deviation) processes including issuance and review

  • Release of raw materials/Assist in PNS revisions

  • Maintenance of Working Cell, Virus bank, Drug Substance and Drug Product inventories

  • Routine compliance monitoring of the shop floor and stock room

  • Other duties as assigned

SCOPE AND DIMENSIONS:

  • This is a Protein Sciences Corporation position located at the Pearl River, NY facility.

  • External/Internal Audit observations and remediation execution

  • Global KPI – Quality Systems

  • Budget adherence

Freedom to act, level of autonomy:

  • The incumbent will make decisions regarding the required interpretation of cGMPs pertaining to Quality Systems and industry guidance to achieve required compliance levels. Position has a high degree of autonomy and is expected to make decisions and interpretations within broadly defined requirements. 

BASIC QUALIFICATIONS:

  • Minimum BS level degree in a relevant science, biomedical or pharmaceutical technical education with experience in and/or knowledge of documentation and quality systems or the combination of experience and training that is equivalent.

  • 2-3 years working experience in a GMP environment

  •  Fluent in English both oral and written

  • Experienced in relevant computer software

  • Organized

  • Able to work within a team

KEY COMPETENCIES:

  • Interpersonal skills, Basic GMP knowledge, detailed oriented, flexible, open minded and the ability to work with cross functional teams

  • This position must interact successfully with the fast-paced project team and have a good understanding of manufacturing process

  • Strong communication skills are critical to ensure teams are guided through cGMP (Quality System) requirements.

Specific details related to environment:

  • This is a Protein Sciences Corporation position with responsibilities based in the Pearl River, NY facility.

  • The position interfaces across all levels of the organization including senior management and across many functional areas such as Manufacturing, MTech, Operations and Regulatory Affairs and Global Quality.

  • This position is Accountable to ensure site compliance to Quality Systems (documentation review and issuance, release, deviations and change controls).

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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