Senior Technical Associate, Quality Assurance TechOps

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, validation reports), supports audits, and helps develop SOPs aligned with regulatory expectations. 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, with final QA review of SOPs for 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 applicable regulations and procedures. Perform 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 of experience in Quality Assurance supporting GMP production, cell therapy, or similar within the pharmaceutical, biologics, or other related industries. Strong understanding and at least five years of experience with aseptic techniques, cell manufacture processes, and technologies. Experience with qualification and validation principles (e.g., Process, Cleaning, Computer Validation, Equipment/Utilities Qualification, Commissioning, Method Validation). Demonstrated ability to interpret cGMP, 21 CFR 210 and 211, and other applicable regulations, standards, and guidance. Knowledge of 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 skills with the ability to convey complex ideas. Independent, detail‑oriented, self‑starter. Ability to manage multiple tasks/projects. Ability to negotiate and influence key partners and suppliers to meet requirements and commitments. Drive for results. Excellent problem‑solver able 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 10 lbs) such as files, binders, or a laptop. Location Parsippany, NJ Compensation & Benefits Base salary range: $100,000 to $125,000. Additional compensation may include an annual bonus based on individual and company performance. Benefits include comprehensive healthcare (medical, dental, vision), a 401(k) plan with company match, disability and life insurance, wellness benefits, tuition reimbursement, paid time off, 15 paid holidays, and paid parental leave (subject to a minimum period of employment). Equal Opportunity Employer 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, 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. #J-18808-Ljbffr Ferring Pharmaceuticals