Quality Operations Specialist II

About the Role At Rose BioSolutions, our capabilities span foundational research with human immune cells and stem cells to the complete advanced therapy manufacturing continuum. We are an established operation with a world-class team of experts, and we apply our R.O.S.E standard to every program and relationship: Reliable, Outcome driven, Scalable, and Excellent! The Quality Operations Specialist II is responsible for reviewing manufacturing Batch Production Records and associated documentation, supporting product shipment and returns, and providing general manufacturing assistance, including line clearing. Additionally, they actively participate in continuous improvement efforts, ensure proper documentation approval, and play a role in preparing lot packages for management’s disposition decision. Upholding a safety mindset and maintaining high standards for work quality are integral to this position. In this position the candidate will assume continued responsibilities of Quality Operations Specialist I. Why Rose BioSolutions At Rose, you are not just another layer in a large organization—you are a key contributor in a nimble, high-impact team. We offer:Direct exposure to diverse and complex client projects across multiple modalities.A collaborative, low-bureaucracy environment where ideas are heard and acted upon.Opportunities to grow your technical expertise and take ownership of your work.Close interaction with leadership and clients, enabling real influence on project outcomes. ESSENTIAL DUTIES AND RESPONSIBILITIES:Provide documentation including logbooks, Quality Control (QC) testing reports, environmental monitoring reports, etc.Perform line clearance and provide general manufacturing supportSupports product shipment and receipt of returnsSupport raw material review and dispositionReview Building Management Systems reports for equipment dataParticipate in departmental and cross-functional continuous improvement effortsConsistently set a high standard for quality of workIssue Batch Production Records and labels to BiomanufacturingServe as owner of assigned nonconformances, Corrective and Preventive Action (CAPA) change controls, or other quality system documents and collaborate to drive completionReview and approve documents in Document Management SystemsPrepare lot packages for disposition decision by managementAssist in training and onboarding new Quality Operations Specialist IObserve live processing, review BPRs and other documents in real time within Cell Processing Facility (CPF) and corridorPractice and adhere to aseptic behaviors while observing in CPFs and corridorsEscalate concerns to quality operations leadership through proper communication channels in a timely mannerDemonstrate the ability to wear the required Personal Protective Equipment (PPE) while performing QOTF DutiesComplete and submit QOTF daily reportsComply with current Good Manufacturing Practices (cGMP)Maintains a safe and healthy work environment by following standards and procedures and complying with legal regulations.Effectively use coaching techniques to help alleviate and resolve minor issuesPerform all other related duties as assigned. QUALIFICATIONS:Bachelors degree in a Life Science and/or related field preferred High school diploma or equivalent requiredMinimum of 2 years GMP related experience in biopharmaceutical/ pharmaceutical and/or related industryExperience with GMP regulatory requirementsAbility to multi-task effectivelyExcellent written and verbal communication skillsAbility to prioritize daily activities to meet client needs within established timelines in a fast-paced environmentProficient in computer system use, including but not limited to Microsoft Office (Word, Excel, Power PointAbility to problem solve and troubleshoot as necessaryConsistently set a high standard for quality of work Promote teamwork and cooperation for departmental and cross departmental task and functions Compensation Data:The pay rate for this role is $56,100- $62,700 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. Why Join Us?Impact: Every process we design is a step toward a cure. You’ll be making a real impact on the health of people in your community and across the globe.Expertise: Work alongside a world-class team of scientists and operational leaders in a "no-ego" environment.Stability & Growth: We offer the security of an established operation with the career growth opportunities of a rapidly expanding organization. Perks & BenefitsCompetitive base salary with performance-based bonus opportunities.Comprehensive health, dental, and vision insurance.401(k) with company contribution.Generous PTO and professional development support. Rose BioSolutions is an equal opportunity employer committed to a diverse and inclusive workforce.