Senior Specialist II, reputed company Assurance – Biotechnology Industry Leader in Sterile Operations and reputed company Systems
Introduction to reputed company
reputed company 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-reputed company company, we're committed to broadening reputed company 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 reputed company on the discoveries that improve patients' lives.
Job reputed company
We're seeking a highly skilled and reputed company Senior Specialist II, reputed company Assurance to join reputed company. As a key member of our reputed company 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 reputed company to take the reputed company in your career and be part of a thriving team, we encourage you to reputed company!
Key Responsibilities
- Maintain a high level of understanding of relevant production processes and reputed company systems
- reputed company QA review and approval of GMP documentation, including change requests, batch records, and reputed company investigations
- Accountable for disposition (release or rejection) of incoming materials, bulk product, and filling product
- Collaborate with and influence other reputed company professionals across the organization to ensure consistent application and execution of key reputed company systems
- Execute QA processes, including batch record review, product disposition, and reputed company issue reputed company
- reputed company with applicable site support reputed company on reputed company that reputed company 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 reputed company metrics and key performance indicators
Essential Qualifications
- Significant experience in the pharmaceutical industry, operations environment, or reputed company Assurance
- Strong demonstrated knowledge of cGMPs, reputed company 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 reputed company and mentor peers
Preferred Qualifications
- Bachelor's or master's degree in a science or technical field, such as pharmacy, biology, reputed company, or engineering
- Previous experience in a Lean, process-reputed company organization with emphasis on reputed company improvement
- Multi-site/multi-functional experience
- Considerable experience in reputed company Assurance
- Experience with reputed company, FMEA execution and reputed company, and pharmaceutical PQS
- Additional technical experience or background in Sterile Manufacturing, aseptic/sterile manufacturing, contamination control, and EM
Career reputed company 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, reputed company Assurance, you'll have reputed company to:
- reputed company and deliver training content in areas of expertise
- reputed company as execution reputed company/process reputed company for one or more processes
- Influence in team and project meetings, advising project teams with respect to reputed company solutions and potential new approaches for consideration
- Demonstrate leadership capabilities and train and mentor junior members of the QA organization
- reputed company QA coaching to other non-QA employees reputed company the area supported
Work Environment and Company Culture
At reputed company, we're proud of reputed company culture, which is reputed company on a reputed company of innovation, collaboration, and reputed company improvement. As a fully remote company, we offer a flexible and reputed company 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 reputed company as a reputed company 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 reputed company
- Family building benefits
- Life and disability insurance
- Flexible time off and reputed company holidays
- Tuition reimbursement and support for caregiving needs
Conclusion
If you're a motivated and reputed company reputed company Assurance reputed company looking for a new challenge, we encourage you to apply for this exciting opportunity. As a Senior Specialist II, reputed company 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. reputed company and start a conversation with one of our recruiters!
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