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Title: Lead Quality Advisor
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration – Permanent
- Pay rate: $100-115K
- Job Location: Winslow, ME
- Job#: bh12309
Lead Quality Advisor
As a member of a team dedicated to ensuring regulatory compliance for a network of vaccine manufacturing sites, the role will:
Partner with external consultants to compare existing practices (Outlines of Production, Batch records, work-instructions, control strategies, etc.) to current compliance requirements (9 CFR)
Develop a strategy (priority, timeline, owners, etc.) for improvements
Actively execute the strategy
Periodically present progress to Executive Leadership
Though developing a strategy is a necessary component of this role, the focus is on the execution of the strategy—completing the improvements identified in the plan. This role will report to the manufacturing Site Head but will have significant exposure to executive leadership throughout the entire process.
Functions, Duties, Tasks:
Partner with functional leaders, Site Head, external consultants, subject matter experts, and executive leadership to develop a compliance roadmap for the vaccine manufacturing site(s)
Responsible for the execution and delivery of improvements through individual assignments and leading project teams
Create, present, and lead training on improvements to processes or procedures
Use technical skills to lead or perform in-depth investigations, which may include participating in or leading change controls and deviations
Communicate progress to off-site steering team
Replicate process for other vaccine manufacturing sites in the network
Minimum Qualification (education, experience and/or training, required certifications):
- Bachelor of Science degree in Biology, Microbiology, Biochemistry, Engineering or another related scientific field.
- Experience with 9 CFR and USDA
- Strong interpersonal communication skills
- Demonstrated ability to execute complex projects
- Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable.
MS or PhD preferred
- Experience providing technical support and/or regulatory support in a manufacturing environment
- Experience in Lean, Six-Sigma or Operational Excellence
- Proficiency with applicable computer systems, such as SAP, Veeva and Microsoft Office
Travel may be required
PPE required in some working areas
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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