Sr. Specialist, Quality Assurance Auditor

  •  

Norwood, MA

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 26 days ago

  by    Faya Lou Bea

Job Summary

Title: Sr. Specialist, Quality Assurance Auditor

Company: Biotech Company

Location: Norwood, MA

Type: Permanent Role

Notes: No Corp to Corp

Job Overview:

The individual in this role will be responsible for providing Quality Assurance (QA) support for Company's Supplier Quality program. The individual will primarily work with Supply Chain and vendors to ensure a robust supply of GMP materials are available to support Company's clinical manufacturing programs. This individual will support supplier quality systems and governance, initiate audit plans, audit vendors, and drive continuous GMP improvement in the supply chain. Works on assignments requiring considerable judgement and initiative. Understands implications of work and makes recommendations for solutions. Additionally, the individual we create and maintain data tracking systems that govern the supplier quality program. The successful candidate must have experience in a biotech or pharmaceutical cGMP environment. Reporting to the Associate Director of Quality Assurance, this person will be responsible for auditing Company's suppliers and will be accountable for monitoring supplier performance.

Responsibilities:

  • Execute supplier audits
  • Partner with supplier to establish relationships
  • Aide in the establishment and maintenance of policies and procedures for the supplier management program
  • Develop Audit Plans
  • Monitor supplier metrics to ensure supplier performance is measurable
  • Maintain supplier data
  • Track supplier conformance to audit commitments and corrective actions (SCAR's)
  • Review supplier change notifications and determine impact to internal systems
  • 60% Travel

Requirements:

  • BS in a scientific or engineering discipline
  • 5-8 + years' experience in pharmaceutical / biotech industry within Quality Assurance executing audits; MSpreferred with 2-5 years' experience
  • Outstanding communication skills (verbal and written)
  • Ability to manage multiple projects in a fast-paced environment
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
  • Has advanced understanding of the job and applies knowledge and skills to complete a wide range of tasks. Familiar with a variety of the field's concepts, practices, and procedures. Requires thorough knowledge of the department and company operations, policies and procedures.
  • High degree of independence. Requires very limited supervision when acting or making decisions within existing policies and practices. Relies on experience and judgment to plan and accomplish goals.

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