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  • Emplois similaires à : Senior Technical Associate, Quality Assurance TechOps
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Senior Technical Associate, Quality Assurance TechOpsFerring Holding SA • Parsippany, New Jersey, United States
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Senior Technical Associate, Quality Assurance TechOps

Ferring Holding SA
  • US
    Parsippany, New Jersey, United States
  • US
    Parsippany, New Jersey, United States
Postuler Maintenant

À propos

The Senior Technical Associate, Quality Assurance ensures compliance with cGMP regulations and internal quality standards. The role reviews and approves quality system documents such as Change Controls, Investigations, CAPAs, protocols, and validation reports; supports audits; and helps develop SOPs aligned with regulatory expectations. The position also analyzes quality metrics, contributes to management reviews, and drives continuous improvement through cross‑functional collaboration. It mentors QA staff and oversees task delegation to maintain high standards of quality and compliance. Responsibilities Quality review and approval of Change Controls, Investigations, Procedures, and CAPAs. Review and approval of protocols, reports, and other commissioning/validation/technical reports. Assist with internal and external cGMP audits. Take the lead in preparing and/or reviewing SOPs related to quality systems. Perform final QA review of SOPs related to Production, Engineering, Facilities/Maintenance, Validation, Supply Chain, and QC. Prepare, review, and approve Test Methods and specifications. Prepare statistical data for monthly, quarterly, and annual Quality Review Metrics. Assist in preparing Quality Review Board presentations to Senior Management. Act as a QA representative for cross‑functional process improvement projects and lead quality continuous improvement initiatives. Assign tasks to QA Technical Associates and provide mentoring and coaching to ensure product quality and compliance with regulations. Perform additional duties as assigned by Quality Management. Qualifications Bachelor of Science degree in Natural Sciences or Engineering from an accredited institution. Seven years of experience in Quality Assurance supporting GMP production, cell therapy, or similar pharmaceutical/biologics industries. At least five years of experience with aseptic techniques, cell manufacture processes, and related technologies. Experience with qualification and validation principles, including Process, Cleaning, Computer Validation, Equipment/Utilities Qualification, Commissioning, and Method Validation. Demonstrated ability to interpret cGMP, 21CFR 210 & 211, and other applicable regulations and guidance. Knowledge of regulatory frameworks for cell and gene therapy, such as GMP, ISO, and medical device development. Knowledge of standard industry documentation, training, and investigations practices. Advanced understanding of quality systems within the pharmaceutical/biopharmaceutical or medical device manufacturing industries. Strong verbal and written communication skills, with ability to convey complex ideas. Independent, detail‑oriented, self‑starter attitude. Ability to manage multiple tasks and projects simultaneously. Skill in negotiating and influencing key partners and suppliers to meet requirements. Drive for results and excellent problem‑solving ability. Proficiency with Microsoft Word, Excel, Access, PowerPoint, and Adobe Acrobat. Physical Job Requirements Occasional standing, walking, and movement between office, laboratory, and manufacturing areas. Capability to wear required personal protective equipment when entering production or lab environments. Ability to lift and carry light materials (typically up to 10lbs) such as files, binders, or a laptop. Location Parsippany, New Jersey, USA Equal Employment Opportunity Statement Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws. Ferring maintains a drug‑free workplace.
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  • Parsippany, New Jersey, United States

Compétences linguistiques

  • English
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