Senior Technical Associate, Quality Assurance TechOps

Responsibilities

• Quality review and approval of Change Controls, Investigations, Procedures, and CAPAs.
• Review and approve protocols, reports, and other commissioning/ validation/ technical reports.
• Assist with internal and external cGMP audits.
• Takes the lead in preparing and / or reviewing SOPs related to quality systems. In addition, 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 as needed and provide mentoring and coaching to ensure product quality and compliance with applicable regulations and procedures.
• Performs other duties as assigned by Quality management.

Requirements

• Bachelor of Science degree in Natural Sciences, and / or Engineering from an accredited college/university.
• Seven years (7) experience in Quality Assurance supporting GMP production, cell therapy, or similar within the pharmaceutical, biologics or other similar industries.
• Strong understanding and experience (5 years) with Aseptic Techniques, cell manufacture processes and technologies preferred.
• Experience with qualification and validation principles (i.e. Process, Cleaning, Computer Validation, Equipment / Utilities Qualification, Commissioning, and Method Validation).
• Demonstrated ability to interpret cGMP, 21CFR 210 and 211, other applicable regulations, standards and guidance.
• Knowledge of applicable regulatory frameworks and requirements for cell and gene therapy, such as GMP, ISO, or medical device development.
• Knowledge of standard industry documentation, training, and investigations practices is required.
• Advanced understanding of quality systems within the manufacturing pharmaceutical/biopharmaceutical or medical device industries.
• Strong verbal and written communication with ability to communicate complex ideas and concepts.
• Independent, detail oriented, self-starter.
• Ability to manage multiple tasks/projects.
• Ability to effectively negotiate and influence key partners and suppliers to meet requirements and commitments.
• Drive for Results.
• Excellent problem-solver with the ability to work independently.
• Proficient in Microsoft Word, Excel, Access, PowerPoint and Adobe Acrobat.
• Physical job requirements:
• Ability to occasionally stand, walk, and move between office, laboratory, and manufacturing areas
• Capability to wear required personal protective equipment (PPE) when entering production or lab environments
• Ability to lift and carry light materials (typically up to 10lbs), such as files, binders, or a laptop
• Role will be in Parsippany, NJ.
• Ferring + you

Benefits

Additional Information

Job Description: As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease. The Senior Technical Associate, Quality Assurance ensures compliance with cGMP regulations and internal quality standards. This role reviews and approves quality system documents (e.g., 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. Additionally, it mentors QA staff and oversees task delegation to maintain high standards of quality and compliance. With Ferring, you will be joining a recognized leader, identified as one of "The World's Most Innovative Companies" by Fast Company, and honored by Fortune with inclusion on its "Change the World List," for addressing society's unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.

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