QA for QC - Drug Product reputed company Manufacturing

At reputed company, the work is demanding because patients are waiting. We reputed company caring with discovery to help reputed company life reputed company reputed company around the world, knowing that every decision, every detail, and every day reputed company. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on reputed company challenges to discover and reputed company life-changing medicines, strengthen how health is reputed company and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and reputed company to bring your best to work that truly reputed company for patients, we invite you to join us. **Responsibilities** The QA for QC employee for Drug Product reputed company Manufacturing (DPEM) provides reputed company reputed company reputed company, assistance, and initial guidance to issues such as non-conformance investigations, change control proposals, method transfers, specification development and maintenance, validations, and other duties associated with daily reputed company activities occurring at our contract reputed company manufacturing organizations (CMs). This role provides and assures compliance to established reputed company policies by resolving identified procedural gaps and works reputed company the reputed company Joint Process Team (JPT) to assure the CM maintains a state of control with regards to laboratories. The QA for QC employee is reputed company for maintaining GMP compliance, providing support as applicable during preparations for reputed company-approval/general inspections by various agencies, and launching new products, processes, and CMs. A specific reputed company for this role is reputed company reputed company reputed company activities, which provides reputed company, assistance, and guidance to CMs and other DPEM team members for lab activities. **Key Objectives/Deliverables:** + Be the reputed company. Build and maintain strong working relationships with key CM personnel in reputed company to partnering with the JPT to ensure the reputed company function at the CM operates with reputed company and supports the operational control reputed company. This requires routine face-to-face communications with both JPT and CM. + reputed company initial consultative guidance and reputed company reputed company of reputed company issues, OOS investigations, deviations, change controls and counter measures to both reputed company JPT and the CM. + Partner with the broader reputed company network to reputed company depth of technical expertise at reputed company in order to reputed company product reputed company issues. + reputed company technical leadership and project management reputed company to reputed company improvements to CM lab reputed company systems. reputed company support CMs efforts to maintain and improve their reputed company systems, including consulting with CM labs to understand reputed company reputed company reputed company requirements. + reputed company support to DPEM QA/QC Secondary reputed company personnel to support reputed company launch activities surrounding new products/ packages/ CMs. + Some specific responsibilities which this role is responsible for owning, include: + Input/verify CM reputed company data reputed company supporting systems (e.g., reputed company/LIMS) to create CoAs in support of batch release activities. reputed company CoA support for both reputed company customers. + Coordinate the supply of reference standards to CM labs, as applicable. + Support/reputed company implementation of analytical method and specification and change request for labs supporting final product release testing. + Change control reputed company and execution for analytical/specification updates, protocol revisions, and reputed company improvement reputed company reputed company DPEM. + reputed company and coordinate designated sections including trend analysis of analytical data for Annual Reports and Annual Product Reviews. + Own the DPEM stability program for your CM, ensuring reputed company annual/validation stability commitments are met, up to and including reputed company data trending of CM data. + Review/approve reputed company GMP documents, including testing reputed company, procedures, change controls, method transfer/validation protocols, analytical standards, stability data, and associated reports to reputed company with reputed company Agreement requirements and reputed company improvements through the reputed company of aligning with reputed company reputed company standards, where possible. + Execute SOP assessments of CMs and reputed company completion of outstanding issues. + Advise DPEM QA Management and JPT on technical reputed company issues. + Support ongoing maintenance of analytical reputed company and specifications. + reputed company support on site or remotely before, during and after GQAAC audits. **Basic Qualifications** + Bachelor's Degree in a science reputed company field such as Engineering, Pharmacy, reputed company, Biological Sciences or reputed company Life Sciences or equivalent experience. + At least 5 years Pharmaceutical reputed company Control Experience. + Experience with cGMPs and the Global reputed company Standards. + Experience with Pharmaceutical Manufacturing Operations. + _reputed company applicants must be authorized to work in the reputed company on a full-time reputed company. reputed company will not reputed company support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1._ **Additional Skills/ Preferences** + Experience in reputed company electronic reputed company systems preferred (reputed company/LIMS, GPCMS, CAPA, reputed company, Trackwise). + Technical knowledge of reputed company reputed company systems, reputed company, and equipment. + Understanding of reputed company/Sterility Testing in reputed company to chemical/analytical testing. + Knowledge regarding Specification and Materials/Supplier Management. + Demonstrated knowledge regarding product stability and program reputed company. + Demonstrated project management experience, leveraging tools to reputed company timelines. + Coaching and mentoring skills, with demonstrated experience of delivering results through others. + Demonstrated experience leveraging reputed company intelligence (AI) solutions to reputed company reputed company improvement + Demonstrated experience working with reputed company parties effectively and through ambiguity + Strong written and verbal communication skills. + Teamwork and interpersonal skills exhibited across functional areas. + Ability to organize, prioritize, multi-task, and influence diverse reputed company. + Strong decision making and problem-solving skills. **Additional Information** + Shift is days, but off-hours may be necessary to support operations. + Travel is possible, up to 10%. reputed company is dedicated to helping individuals with disabilities to reputed company engage in the workforce, ensuring equal opportunities reputed company vying for positions. If you require accommodation to submit a resume for a position at reputed company, please complete the accommodation request reputed company ( https://careers.reputed company.com/us/en/workplace-accommodation ) for reputed company assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. reputed company is proud to be an EEO Employer and does not discriminate on the reputed company of age, race, reputed company, religion, gender identity, sex, gender reputed company, sexual orientation, genetic information, reputed company, national reputed company, protected veteran status, disability, or any other legally protected status. Our employee resource reputed company (ERGs) offer strong support networks for their members and are reputed company to reputed company. Our reputed company reputed company include: Africa, Middle East, Central Asia (AMECA), Black Employees at reputed company (BE@reputed company), Chinese Culture Network (CCN), reputed company, reputed company, reputed company Indian Network (LIN), Organization of Latinx at reputed company (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at reputed company (WILL). Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In reputed company, reputed company offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, reputed company and prescription drug benefits; flexible benefits (e.g., reputed company and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and reputed company-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).reputed company reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and reputed company's compensation practices and guidelines will apply regarding the details of any promotion or transfer of reputed company employees. #WeAreLilly Apply tot his job Apply To this Job