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All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
This posting is for a position on the QA Drug Product team supporting deviations and providing real time quality impact support (including off shift and weekends) in Kalamazoo Drug Product Operations. The colleague will need to effectively work/communicate with key stakeholders and peers to ensure timely completion of non-conformance investigations reports with effective corrective/preventative actions (CAPA).
Independently provide Real Time Quality impact assessments and decisions (24/7) on Drug Product issues as needed:
• Ability to handle complex and detailed situations
• Accurately assess consequences of decisions
• Accurately assess potential Regulatory impacts on a Global basis
• Immediately escalate issues with potential market or stability impact
• Accurately communicate Supply/Operational needs/perspectives as well as QO perspectives.
• Participates in and leads QAR Gembas with customers and peers
• After initial assessment of QARs and ERs, successfully transitions remainder of investigation to others to complete investigation write up as needed
• Effectively leads/facilitates/participates/completes cross-functional team investigations for FARs and Significant Deviations and when applicable aids in drafting of AQRT summary
• Utilize tools such as Method 1 and the company Human Performance in the course of the investigations
• Participate in QRM assessments that gain approval through Site and Area QO Management
• Participate in Green/Black belt projects, RFT% Improvement projects, CAPA Effectiveness, etc... as appropriate
• Propose and implement improvements in the Deviation and/or Floor Support operations
• Independently assess a wide range of Change Control activities (PTVAs, Protocol development, SOP and MBR changes) to determine potential Quality and Operational GMP impacts
• SME support during Regulatory/Customer audits including contributions to strategies to successfully respond to auditor concerns
• Participates in internal GMP audits
• Effectively communicate complex technical issues to all levels of Management (including outside of Quality)
• Actively demonstrate the company leader behaviors.
Education: BS in Chemistry, Biochemistry, Microbiology, Engineering or other science related discipline
Experience: Minimum 2 years pharmaceutical experience.
Preferred but Not Required: Experience writing and managing deviations.
Office position with significant time in the production environment.
Independently, with minimal guidance, consistently produces quality work. Must be able to work in a team environment within own team and interdepartmental teams. Must work under short timelines while maintaining quality work. Must have effective written and oral communication skills.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Support deviations and provide real time quality impact support (including off shift and weekends) in Kalamazoo Drug Product Operations. Colleague will be trained in aseptic gowning.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
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