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Job Description:As a privately-owned,biopharmaceutical company, Ferringpioneers anddeliverslife-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, whileremainingagile 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.Associate Quality & Technical Support will provide Quality Assurance (QA) oversight for commissioning, qualification, and validation activities at the manufacturing site, including review and approval of all associated documentation. The position supports quality systems, investigations, change controls, aseptic operations, and regulatory compliance across multiple functional areas. The individual will serve as a QA representative for site projects and will support both routine operations and strategic initiativesWith 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:Commissioning / Qualification / Validation Oversight- Quality representative for review and approval of commissioning, qualification, and validation documentation, including protocols, reports, risk assessments, traceability matrixes, and technical studies.- Oversight of Process Validation, Cleaning Validation, Computer Validation, Equipment & Utilities Qualification, Method Validation, commissioning activities, and shutdown-related activities.- Review of design qualifications, user requirement specifications, software/hardware design specs, functional requirements, FAT/SAT, media fills, smoke studies, and protocol deviations.Quality Systems & Documentation- Review and approval of Change Controls, Investigations, CAPAs, Procedures, and technical reports.- Prepare, review, and/or approve SOPs related to Quality Systems, and provide final QA review for SOPs from Production, Engineering, Facilities/Maintenance, Validation, Supply Chain, and QC.- Review, approve, and close Change Controls for equipment, utilities, QC, process, batch records, and component changes.Complaints, APRs, Metrics & Reporting- Prepare and review complaints for products manufactured at the site.- Prepare and review Annual Product Reports (APRs).Project & System Support- QA representative for development and implementation of new systems/modules such as EBR and LIMS.- Review and approve test methods, labeling, packaging component specifications, and LIMS analyses.- Provide QA support for site-level special projects.Audits & Compliance- Assist with internal and external cGMP audits, including FDA, EMA, ISO, and other regulatory/third-party inspections.- Ensure compliance with cGMP, 21 CFR 210/211, and relevant regulations for pharmaceuticals, biologics, and cell/gene therapy.General- Perform other duties as assigned by Quality Management.Requirements:- Bachelor of Science in Natural Sciences or Engineering from an accredited college/university.- Minimum 5years of experience in GMP Quality Assurance, Manufacturing, Validation, or Technical Services in pharmaceutical, biologics, medical device, or cell therapy industries.- Minimum 3 years of experience with aseptic techniques, cell manufacturing processes, or related technologies strongly preferred.- Experience reviewing or executing Process Validation, Cleaning Validation, Computer Validation, Equipment/Utilities Qualification, Commissioning, and Method Validation.- Support occasional off-shift activities (early morning, evening, or weekend) related to validation runs, shutdowns, or regulatory inspections- Strong understanding of cGMP, 21 CFR 210/211, FDA/EMA regulatory expectations, and relevant guidelines.- Familiarity with standard industry documentation practices, training systems, investigations, and deviation management.- Knowledge of quality systems including TrackWise, LIMS, EBR, SAP, and related platforms.- Strong analytical, problemsolving, and technical writing skills with the ability to interpret complex data and concepts.- Detailoriented, independent, able to manage multiple tasks and influence crossfunctional teams.- Proficiency with Microsoft Word, Excel, Access, PowerPoint, and Adobe Acrobat.Physical Requirements:- Stand for extended periods during facility walkthroughs, validation observations, and audits- Climb stairs regularly and occasionally use ladders or step stools when accessing equipment or utility areas- Bend, stoop, kneel, or crouch when reviewing equipment installations, process connections, or sampling points- Lift, move, or transport materials, documents, or portable equipment weighing up to 20 pounds- Wear appropriate gowning and personal protective equipment (PPE) when applicable- Support occasional off-shift activities related to validation runs, shutdowns, or regulatory inspectionsRole will be in Parsippany, NJ.Ferring + youAt 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 andequitable, and the chance to work with the industry's most impressive people, these are just some of the ways weliveour "People First" philosophy.Our Compensation and BenefitsAt Ferring,basesalary is one part of our competitive total compensation and benefits package and isdeterminedusing a salary range. The base salary range for this role is $95,000 to $110,000, 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,educationand 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 to120 hoursin the first four (4) years of employment, and160 hoursin the fifth (5th) year of employment as well as15paid holidays per year.We are proud to offer paid parental leave subject to a minimum period of employment at Ferring.Ferring is an equalopportunityemployer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminateon the basis ofrace, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, p regnancy, geneticinformation, 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 tocome up withnew ways to make a positive difference and see them through, you will fit rightin.We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). Wemaintaina drug-free workplace.Location:Parsippany, New JerseyWe are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled