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Quality Assurance Specialist

Location

Port Washington, NY

Description

POSITION PURPOSE:

The purpose of the Quality Assurance Specialist is to perpetuate Enterprise-wide Quality and Regulatory compliance and continuous improvement through the administration of the Supplier Quality Program and other initiatives that support the overarching Quality Management System and processes.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • This function provides expertise to the External Supplier Quality functions supporting product manufacture and site operations in order to assure reliable, repeatable production of safe, pure, and efficacious products that function as intended.
  • This incumbent serves as a key contact for the business and retail units, and will interact routinely with Supply Chain Management, Operations, R&D, Sales and Marketing as well as Corporate and Site Quality and Regulatory Affairs.
  • The incumbent will provide expertise in internal/ external auditing to assess conformance to applicable requirements.
  • S/He will engage in Quality partnership with suppliers and contract manufacturers. ensuring the appropriate inputs and output measurement to assure that manufacture and distribution of products are within standards as well as all applicable regulations.
  • This position requires both strategic and tactical skills to drive positive change through supplier partnerships, as well as manage the multiple activities concurrently.

 

AUDITS, INSPECTIONS, AND COMMITMENTS:

  • Manage applicable Compliance projects for Regulatory and Customer implementations.
  • Participate in organization and execution of audits and inspections, including personnel, requests, documentation, and process flow.
  • Ensure accurate, thorough, and on-time completion of all Agency and Third-Party Commitments.
  • Maintain documentation and records in accordance with regulations and internal policies.

 

CUSTOMER SERVICE:

  • Assist internal customers with technical support and status inquiries.
  • Provide copies of documentation for internal and external distribution.
  • Liaise with Division Leads; e.g., Retail, to ensure appropriate support to External customers.

 

REPORTING & ANALYSIS:

  • Create monthly trending reports and metrics for Quality Review Committee (QRC), Quality/Regulatory Management Team (QRMT), and others as appropriate.
  • Deliver departmental metrics as requested.
  • Analyze and plan upgrade strategies to ensure compliance.

 

PERFORMANCE MEASUREMENTS:

  • Robustness of Programs
  • Regulatory and GMP Compliance
  • On-time Completion
  • Effective Metrics and Reporting
  • Values - Centered Execution

 

Requirements

REQUIRED KNOWLEDGE: 

  • Internalized knowledge of GXP requirements for the Regulated environment for Pharmaceutical or Medical Device manufacture.
  • Proficiency in standard computer systems and applications.

 

SKILLS/ABILITIES: 

  • Breadth of knowledge to sufficiently navigate and convey the requirements for the GMP Quality System in accordance with FDA regulations and ISO Standards.
  • Strong positive influencer skills are required; must be able to train, coach and motivate Associates to effect a culture of Quality and compliance.
  • Previous supplier quality experience, including auditing, is a plus.
  • Strong written and verbal communication skills with all organizational levels and external partners.
  • Ability to coordinate cross-functional teams and facilitate troubleshooting of complex problems a plus.
  • Ability to meet needs of Enterprise by effective prioritization and task balancing.

 

EDUCATION AND EXPERIENCE:

  • Education: B.S. or B.A. degree in Information Technology, Life Sciences, or applicable business function, or a combination of education and experience, a plus.
  • Experience: At least 2 years in a Quality role with at least 1 year of auditing experience.

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