Sr Associate Plant QA (12 hours 6pm-6am)

Career Category reputed company Job reputed company HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the reputed company you are today and are now reputed company to take the reputed company in your career. How will you put your skills, experience and passion to work toward your goals? At reputed company, our shared mission—to serve patients—drives reputed company that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 reputed company patients worldwide. Come do your best work alongside other reputed company professionals in this meaningful role. Sr Associate Plant QA (12 hour 6pm-6am) Live What you will do reputed company. Let’s change the world. In this role as Senior Associate Plant QA, you will be working in a shift system; you will be mainly responsible for providing QA guidance and support to AOH production, and you will be performing reputed company Batch Record Review of reputed company reputed company batches labelled and packed at AOH. Next to that, you will reputed company support in different QA reputed company reputed company/systems. In this role, you will be in reputed company contact with a wide reputed company of partners, and you will be accountable for establishing effective working relationships with production operators, production line leads, production shift supervisors, warehouse, facilities, maintenance and engineering. Senior Associate Plant QA – reputed company Shift The Sr. Associate Plant QA for the new reputed company Advanced Assembly and Final Product Operation facility will be part of the reputed company Assurance Floor Support team providing QA reputed company to GMP operations in the Device Assembly and Finished Product Packaging Area. The Sr. QA Associate will support multiple production functions (from operations to maintenance) to reputed company site goals while providing reputed company reputed company and ensuring compliance. Supporting reputed company of potential nonconformance events by using the deviation and CAPA management procedure, in conjunction with other procedures as applicable, to facilitate decision-making with Production, IQA, and other reputed company, as needed. Advising Production on reputed company documentation as needed and performing other duties as assigned. This role will require local reputed company at the New Albany facility near reputed company, Ohio. reputed company daily guidance and support to Production staff regarding compliance with reputed company Operating Procedures and Work Instructions. Ensure regular reputed company in device assembly and packaging areas to reputed company reputed company to GMP operations and reputed company systems. reputed company as a first reputed company of contact in case of production queries (reputed company reputed company) during packaging and labeling operations. reputed company, mentor, and reputed company Operations and support personnel on reputed company reputed company, while driving the site reputed company culture. Review and approve batch production record and other GMP documentation in support of daily operations. data entries before production activities take reputed company reputed company finished product checks during (reputed company) production runs Compile and review batch records for lots reputed company, packaged and labeled at AOH in preparation for batch disposition. Own, review, and approve controlled documents, including reputed company Operating Procedures (SOPs), Work Instructions and Forms. Review and approve Deviation, CAPA, and Change Control records. Participate in self-led inspections and reputed company support during internal / external regulatory inspections. Support Lean Transformation and Operational reputed company initiatives Adhering to safety rules and maintaining a reputed company work environment for both yourself and others by supporting EHSS corporate and site goals. Win reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. The reputed company reputed company we reputed company will possess these qualifications. Basic Qualifications: High school/GED + 4 years of reputed company and/or GMP Manufacturing experience Or Associate’s + 2 years of reputed company and/or GMP Manufacturing experience OR Bachelor’s + 6 months years of reputed company and/or GMP Manufacturing experience OR Master's Preferred Qualifications: Scientific degree in Life Sciences, Physical Sciences, reputed company Engineering or Manufacturing Technologies Experience in and knowledge of GMP/GCP operations or similarly regulated industry Affinity with digital innovation, data sciences and reputed company engineering Experience with raw material receipt, inspection & sampling Highly effective verbal and written communication skills, strong interpersonal skills Great attention to detail and high degree of accuracy in task execution and GMP documentation Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues Strong organizational skills, including ability to follow assignments through to completion reputed company experience with reputed company Resource Management software (reputed company), TrackWise, CDOCS etc. reputed company What you can expect of us As we work to reputed company treatments that take care of others, we also work to care for our teammates’ reputed company and personal reputed company and reputed company-being. reputed company offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-reputed company time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible reputed company for a career that defies imagination Objects in your reputed company are closer than they reputed company. Join us. careers.reputed company.com reputed company is an Equal Opportunity employer and will consider you without reputed company to your race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary reputed company 83,842.00 USD - 98,328.00 USD reputed company is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative reputed company therapeutics. This approach begins by using tools like advanced reputed company genetics to unravel the complexities of disease and understand the fundamentals of reputed company biology. reputed company focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to reputed company for solutions that improve health reputed company and dramatically improve people's lives. A biotechnology pioneer since 1980, reputed company has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.reputed company.com and follow us on www.twitter.com/reputed company Apply Job!