QA Specialist II - Quality Systems and Compliance - Audits

About the RoleAt 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 QA Specialist II - Quality Systems and Compliance - Audits is responsible for the management and coordination of the site's Internal Audit program, Supplier Management Program and Client Audits. This position will facilitate compiling, trending (as required), and reporting key quality metrics for management, and other quality system functions, as needed. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products. This includes but is not limited to the following: Why Rose BioSolutionsAt 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. Key ResponsibilitiesInternal Audits -Collaborate cross-functionally to ensure adherence to the site IA schedule.Ensure reports and responses and CAPA are performed in a timely mannerPerforms CAPA effectiveness evaluation based on quantitative and qualitative measurements.Serve as the lead auditor, as necessaryClient AuditsMaintain the client audit schedule for the site,Host client audits, ensure that audit responses and CAPA are performed in a timely mannerPerforms CAPA effectiveness evaluation based on quantitative and qualitative measurements.Supplier AuditsProvide QA oversight of the Supplier Management program.Conduct Supplier audits, serving as the lead auditor, as necessary.Complete assessments of new suppliers and changes to scope of work for approved suppliers.Coordinate and manage 3rd party Supplier auditorsCollaborate to ensure the site Approved Supplier List is maintainedCollaborate with Rose BioSolutions global QA to facilitate harmonization of processes.Maintains tracking mechanisms to support various Quality Systems elements and ensures visibility throughout the organization.Continuously monitors and review systems and procedures for adherence to regulatory compliance, quality improvements, efficiency, and industry best practices. Provide compliance support and expertise for QA department.Compiles and reports site monthly corporate Quality metrics and supports the Quarterly Management Review (QMR).Develops, implements, and delivers training content for auditing and related quality systemsResponsible for procedure reviews and facilitating procedure updates for audit systems.Identifies and escalates compliance gaps across quality systems.Additional duties as assigned. Qualifications and ExperienceBS/ BA in life sciences or related fields.Minimum 5 years of experience in performing GMP Quality Audits or related experience in biopharmaceutical/ pharmaceuticalStrong knowledge of GMP, SOPs and quality system processes.Excellent organizational skills and ability to review and update processes or procedures.Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic quality management systems. Previous experience in Track Wise, Pilgrim is preferable.Strong written and verbal communication skills.Experience in pharmaceutical or bio-pharmaceutical field.Proficient in drafting and completing technical documents and presentations.Expertise in document management processes.Works on multiple assignments in collaboration with various department system owners.Quality systems demonstrated knowledge in areas such as Audits, Deviation, CAPA, and Change Control system management practices/strategies.Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/600/820, ICH and EMA).Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.Demonstrates basic understanding of training, instructional design, communication and/or education.Demonstrates knowledge and understanding of pharmaceutical manufacturing and quality assurance, aseptic and packaging processes, and product transfer.Demonstrates presentation skills with the ability to conduct training sessions.Proven organizational skills, planning skills and ability to work effectively within teams.Demonstrates ability to lead cross-functional project teams. COMPENSATION DATA:The pay range for this position is $80,000- $95,000 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.