Senior Technical Associate, Quality Assurance TechOps

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.

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


At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are just some of the ways we live our "People First" philosophy.


Our Compensation and Benefits


At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $100,000 to $125,000, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.

Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 15 paid holidays per year. We are proud to offer paid parental leave subject to a minimum period of employment at Ferring.

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.


Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.


We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.


Location:
Parsippany, New Jersey