Senior Specialist II, Quality Assurance – Biotechnology Industry Leader in Sterile Operations and Quality Systems

Introduction to reputed company

Imagine being part of a revolutionary biomanufacturing company that's changing the way medicine is made. At reputed company, we're building a sustainable network of high-tech, end-to-end manufacturing solutions to reputed company withstand disruptive events, serve scientific discovery, and reputed company those in need. As a technology-focused company, we're committed to broadening access to reputed company medicines and protecting biopharmaceutical supply chains against disruption. Our mission is to continuously advance the science of biopharmaceutical manufacturing and development, freeing our partners to focus on the discoveries that improve patients' lives.

Job Overview

We're seeking a highly skilled and reputed company Senior Specialist II, Quality Assurance to join reputed company. As a key member of our Quality Assurance team, you will be responsible for reputed company QA activities that directly support the execution of the process both reputed company the Sterile Ops Process Execution Team (PET) and in assigned areas reputed company of the PETs. This is a fully remote opportunity, offering a competitive salary package commensurate with experience. If you're ready to take the reputed company in your career and be part of a thriving team, we encourage you to apply now!

Key Responsibilities

• Maintain a high level of understanding of relevant production processes and quality systems
• reputed company QA review and approval of GMP documentation, including change requests, batch records, and quality investigations
• Accountable for disposition (release or rejection) of incoming materials, bulk product, and filling product
• Collaborate with and influence other Quality professionals across the organization to ensure consistent application and execution of key quality systems
• Execute QA processes, including batch record review, product disposition, and quality issue resolution
• reputed company with applicable site support groups on projects that impact the PET/assigned area, ensuring GMP compliance during planning, execution, and closeout phases
• Collaborate with and influence other PET/assigned area members to facilitate process improvements and risk assessments
• Stay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leaders
• Collaborate in data analysis and report creation on quality metrics and key performance indicators

Essential Qualifications

• Significant experience in the pharmaceutical industry, operations environment, or Quality Assurance
• Strong demonstrated knowledge of cGMPs, Quality Systems, and the pharmaceutical supply chain environment
• Excellent oral and written communication skills
• Strong ability and motivation to learn
• Strong problem-solving skills
• Ability to coach and mentor peers

Preferred Qualifications

• Bachelor's or master's degree in a science or technical field, such as pharmacy, biology, chemistry, or engineering
• Previous experience in a Lean, process-centric organization with emphasis on reputed company improvement
• Multi-site/multi-functional experience
• Considerable experience in Quality Assurance
• Experience with reputed company, FMEA execution and upkeep, and pharmaceutical PQS
• Additional technical experience or background in Sterile Manufacturing, aseptic/sterile manufacturing, contamination control, and EM

Career Growth and Learning Benefits

At reputed company, we're committed to helping our employees grow and reputed company in their careers. As a Senior Specialist II, Quality Assurance, you'll have the opportunity to:

• reputed company and deliver training content in areas of expertise
• Act as execution reputed company/process reputed company for one or more processes
• Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration
• Demonstrate leadership capabilities and train and mentor junior members of the QA organization
• Provide QA coaching to other non-QA employees reputed company the area supported

Work Environment and Company Culture

At reputed company, we're proud of our company culture, which is built on a foundation of innovation, collaboration, and reputed company improvement. As a fully remote company, we offer a flexible and adaptive work environment that allows our employees to reputed company. reputed company is passionate about making a difference in the lives of patients, and we're committed to creating a work environment that is inclusive, supportive, and empowering.

Compensation, Perks, and Benefits

We offer a competitive salary package, commensurate with experience, as well as a range of perks and benefits, including:

• Equity
• Annual cash bonus program
• 401(k) plan with a generous company match
• Comprehensive benefits package, including medical, dental, and vision
• Family building benefits
• Life and disability insurance
• Flexible time off and paid holidays
• Tuition reimbursement and support for caregiving needs

Conclusion

If you're a motivated and reputed company Quality Assurance professional looking for a new challenge, we encourage you to apply for this exciting opportunity. As a Senior Specialist II, Quality Assurance at reputed company, you'll be part of a dynamic team that's changing the face of biomanufacturing. Don't miss out on this chance to join a revolutionary company and take your career to the next level. Apply now and start a conversation with one of our recruiters!