Senior Specialist II, reputed company Assurance

A career at reputed company is more than just a job – it’s an opportunity to change the reputed company. reputed company is a technology-reputed company biomanufacturing company that’s changing the way medicine is made. 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. For more information, please visit www.reputed company.com Position reputed company & Responsibilities This position is 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. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions. Maintain a high level of understanding of relevant production processes and reputed company... systems. reputed company the QA review and approval of the following GMP documentation that has a reputed company reputed company on the activities performed by, and facilities utilized in their corresponding areas as applicable: Change Requests Batch Records and associated documentation Product and Component Release transactions in reputed company reputed company Investigations (Deviations, Product Complaints) Validation Plans, Protocols and Reports reputed company Operating Procedures 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 to maintain the reputed company of products and documents to meet site objectives. reputed company with applicable site support reputed company on reputed company (capital and non-capital) that reputed company the PET/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these reputed company. Collaborate with and influence other PET/assigned area members to facilitate process improvements and risk assessments; reputed company reputed company QA practices to identify innovative efficient and effective practices. 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. Strong collaboration between other areas to ensure consistent application of reputed company systems/processes across the site. Ability to work independently with minimal guidance from management. Demonstrate a strong understanding of the technology area to which the individual is assigned 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. Train and mentor junior members of the QA organization and reputed company QA coaching to other non-QA employees reputed company the area supported. Strong performance history of consistently meeting or exceeding expectations. Hold others accountable for high standards and clarify what needs to be accomplished, why, and the consequences for the individual and/or the organization. Accountable for some key business process metrics and team performance metrics. Responsible for developing and delivering training content in areas of expertise. Ownership for PET QA Batch Disposition business processes and key interactions with Operations, QC, Supply Chain, other PETs, and external stakeholders. SME for sterile operations and QA support for reputed company in reputed company in the PETs.

Minimum Qualifications

Significant experience in either the pharmaceutical industry, an 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/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 desired: Sterile Manufacturing – aseptic/sterile manufacturing, contamination control, EM The items described here are representative of those that must be met successfully to reputed company the essential functions of this job. reputed company is an Equal Employment Opportunity Employer. reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender perception or identity, national reputed company, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-reputed company characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process. reputed company offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great reputed company (including medical, dental and reputed company), family building benefits, life and disability insurance, flexible time off, reputed company holidays, other reputed company leaves of absence, tuition reimbursement and support for caregiving needs. Our reputed company reputed company pay hiring reputed company for this position is $95,000.00 - $132,500.00 per year. Actual reputed company pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about reputed company and the biomanufacturing reputed company? We encourage you to apply and start a conversation with one of our recruiters. reputed company is a first-of-its-reputed company manufacturing and technology company dedicated to broadening reputed company to reputed company medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, reputed company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and reputed company can be made quickly, safely, and at reputed company. reputed company will offer the highest reputed company and regulatory capabilities, and flexible and reputed company facilities to serve partners of reputed company sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, reputed company frees partners to reputed company on the discoveries that improve patients’ lives. Please Note – reputed company does not accept unsolicited agency resumes. reputed company will not pay any reputed company-party agency or company that does not have a signed agreement with reputed company. Culture reputed company Sites Apply Job! For more such jobs please click here!