The position will participate and/or lead quality improvement project teams across a variety of global operational departments to identify and implement significant improvements to quality systems and business processes.
Responsibilities will include but are not limited to: Lead and/or participate on quality improvement project teams; Assess current processes and analyze quality metrics to identify opportunities for improvement; Work with cross-functional teams to implement new ways of working to improve quality and compliance; Utilize variety of quality improvement tools (e.g., FMEA, Fishbone); Perform data and trend analysis, reports metrics to site and global management; Provide support for regulatory inspections; Lead and/or participate in trend or other critical impact investigations; Lead projects related to mitigation of risks highlighted on the Risk Register.
Who You Are:
· Bachelor’s degree in scientific or technical discipline (i.e. Biology, Biotechnology, Engineering, etc.)
· 3+ years’ experience in quality assurance or applicable technical role
· 2+ years' experience working on process improvements projects
· Certification in quality engineering, quality improvement, and/or six sigma
· Acts ethically and ensures quality of own work and that of others
· Works with agility and willing to embrace and implement change on a global scale
· Applies technology to drive digitalization, improve quality and increase customer value
· Excellent communication and facilitation skills (ability to lead cross-functional meetings, demonstrated ability to bring consensus among diverse cross-functional teams)
· Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity)
· Advanced skills in data analysis applications (e.g., Microsoft Excel, other statistical analysis tools)
Job Requisition ID: 198326
Career Level: C - Professional (1-3 years)
Working time model: full-time
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.
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