Quality Assurance Analyst

Stefanini Group is hiring!

Stefanini is looking for Quality Assurance Analyst in Indianapolis IN or Byhalia MS or Deerfield IL

For quick Apply please reach out to Vipul Bhardwaj - call: / email:

Work Hours:M-F (40 hours)

Work Location:Indianapolis IN or Byhalia MS or Deerfield IL (Hybrid)

Shift:1st Shift

The Quality Associate supports the setup and qualification of a new third party logistics (3PL) partner ensuring distribution activities comply with GxP FDA and quality system requirements for medical device and pharmaceutical products. This role partners closely with Fulfillment Supply Chain and Manufacturing teams to establish compliant processes documentation and oversight for regulated product distribution.

Responsibilities:

• Support the qualification onboarding and ongoing oversight of a new 3PL partner to ensure compliance with applicable GxP FDA and ISO requirements.
• Partner closely with Fulfillment Supply Chain and Operations teams to establish compliant distribution and warehousing processes.
• Review approve and help implement quality agreements SOPs and work instructions related to 3PL activities.
• Conduct and support vendor qualification activities including risk assessments and audits (on site or remote).
• Ensure proper handling of temperature controlled regulated and serialized products as applicable.
• Support deviation investigations CAPAs and change controls associated with 3PL operations.
• Assist with setting up and maintaining documentation records and training requirements for the 3PL partner.
• Monitor 3PL performance through metrics quality KPIs and periodic reviews.
• Support regulatory inspections and internal audits involving distribution and logistics processes.
• Serve as a quality liaison between the company and the 3PL to drive continuous improvement and compliance.

• Bachelors degree in Quality Life Sciences Engineering or a related field.
• Experience in a regulated environment (medical device pharmaceutical or biotech).
• Working knowledge of GxP FDA regulations and quality systems related to distribution and logistics.
• Experience supporting or interacting with third party vendors or 3PL partners preferred.
• Strong documentation communication and cross functional collaboration skills.
  
  

Listed salary ranges may vary based on experience qualifications and local market. Also some positions may include bonuses or other incentives.

Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.

About Stefanini Group

The Stefanini Group is a global provider of offshore onshore and near shore outsourcing IT digital consulting systems integration application and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas Europe Africa and Asia and more than four hundred clients across a broad spectrum of markets including financial services manufacturing telecommunications chemical services technology public sector and utilities. Stefanini is a CMM level 5 IT consulting company with a global presence. We are CMM Level 5 company.

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