Title:  Assoc, Quality Systems

Job Summary

In this Associate Quality Compliance role, the incumbent will provide quality support through internal and external customer engagement. Provide support for product and process improvements by collecting, compiling and analyzing data.  Support continuous improvement projects relating to both sustaining engineering and product development activities.  Participate in steering committees which originate from both corporate and manufacturing facilities.  Support customer complaint data acquisition, root cause analysis and draft complaint responses.   

Essential Duties and Responsibilities

• Review and approve procedures, work instructions, CAPA, and other quality documentation as necessary.
• Interact with internal and external clients as needed.
• Support both corporate and facility complaint entry.
• Prepare and send complaint reports to Customers
• Maintain and report KPI Metric and Bonus Metric Data
• Lead and conduct root cause analysis utilizing available tools to drive continuous improvement.
• Provide quality reports and analyze and interpret data for quality trends
• Work independently and with project teams to develop design control deliverables.
• Participate in the development and maintenance of product risk and hazard analysis in accordance with ISO 14971.
• Support quality assurance improvement activities 
• Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions.

Education

• Bachelor’s degree in or equivalent experience in quality related discipline.

Work Experience

• 2 – 5 Years of experience with a minimum 2 years’ experience in a regulatory (ISO, cGMP) environment required.
• Previous employment within the pharmaceutical industry preferred.

Preferred Knowledge, Skills and Abilities

• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
• Must possess or be willing to develop:
  • Problem solving skills, preferably Lean Six Sigma Green Belt with DOE experience.
  • Effective presentation/communication skills, both oral and written, project/resource management skills.
  • Must be able to travel by air and car and work occasional weekends.
  • Comply with safety regulations and promote safe working environment.
  • Ability to manage multiple projects in a fast-paced environment.
• Knowledge of ISO 9001:2015, ISO 15378, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP
• Ability to work independently and in a team environment
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target

License and Certifications

#LI-CS1

Travel Requirements

Physical Requirements