Field Validation Specialist

🕒 il y a 8 jours

🇺🇸 États-Unis – Télétravail

💵 $69 422 - $104 134 / an

⏰ Temps Plein

🟢 Junior

🟡 Intermédiaire

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 0%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Grifols

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1909

🏥 Santé

🏭 Fabrication

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Grifols est une entreprise mondiale de santé dédiée à l'amélioration de la santé et du bien-être des personnes à travers le monde. Elle se concentre sur le développement, la production et la distribution de médicaments innovants dérivés du plasma et a un engagement fort envers la recherche et le développement dans le secteur pharmaceutique. Grifols vise à fournir des solutions pour les patients atteints de maladies rares et de conditions chroniques, contribuant de manière significative au domaine de la biotechnologie et des soins de santé.

Description

• Ensure current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout validation protocol performance, documentation, and review • Execute freezer installation, operational, and performance qualifications on-site at donor centers and affiliated locations • Interact with Donor Center and Field Quality/Operations personnel to facilitate timely, documented validation approval • Analyze validation data to ensure acceptance criteria are met • Participate in writing validation summaries • Communicate with Field Quality/Operations and Operational and Quality Assurance personnel regarding compliance and cGMP issues • Write test cases to validate critical control points, user requirements, and functional designs • Execute test cases as needed • Prepare validation reports for distribution • Ensure milestones and timelines are met on assigned projects • Prepare validation equipment for Donor Center use and evaluation upon return • Assist in identifying actions to add, remove, and/or revalidate processes, systems, and equipment • Evaluate new or updated methodologies, applications, and equipment and help resolve performance, transfer, or service issues • Track and monitor process/system failures and events • Provide Donor Center management with feedback on requirements, collected data, and validation processes • Track and monitor equipment calibration due dates and calibration failures/events • Prepare donor center staff for validation activities and conduct training where applicable • Travel on-site up to 75% to ensure timely validation completion

🎯 Exigences

• Bachelor's degree • Typically 2 years of quality and validation experience in a cGMP and/or IT environment • Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures • Excellent quantitative and analytical skills • Excellent oral and written communication skills • Strong critical thinking and problem solving skills • Ability to identify errors and provide corrective action • Ability to work with others in a team environment • Knowledge of Microsoft Office applications and computer applications used in the Donor Centers • Ability to travel on-site up to 75% as needed • Ability to work in office and laboratory/manufacturing environments • Ability to work around biological fluids, potential infectious organisms, extreme cold, and high noise levels • Ability to use required personal protective equipment • Ability to lift and carry objects up to 50 lbs • Correctable near and far vision as specified in the Occupational Demands Form • Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements

🏖️ Avantages

• Up to 5% of the company bonus pool • Medical insurance • Dental insurance • Vision insurance • Life insurance • PTO • Paid holidays • Up to 5% 401(K) match • Tuition reimbursement • Professional growth and career progression opportunities