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Quality Assurance Assistant

4 months ago

Fair Lawn, New Jersey, United States Suan Farma, Inc. Full time
From Suanfarma we are looking for an Assistant to join our QA team, located in New Jersey.

REQUIREMENTS:

  • Demonstrated previous experience in administrative positions.

RESPONSIBILITIES:

SUPPORT TO THE QA MANAGER IN THE FOLLOWING ACTIVITIES:

  • Assure consistent quality of the materials and support documentation is delivered to our customer by developing and enforcing good manufacturing and distribution practices and compliance with all federal, state and municipal regulations.
  • Establish good and permanent working relationship with Agencies and Authorities on behalf of SuanFarma, partner companies and key stakeholders.
  • Contact person with third party logistics & clients for internal quality compliance matters.
  • Communicate with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations.
  • Review and evaluate the documentation (company, certifications, product information) received from manufacturers and suppliers.
  • Supervise the reception product assuring the compliance of the material with the approved specifications and release for storage.
  • Prepare and maintain updated the product documentation (COA, Tech Pack, Declarations, Statements, MSDS).
  • Prepare an answer to all questions and additional information requests (questionnaires, forms).
  • Review of processing records to support product shipment release requirements.
  • Support and cooperate in the SF USA product entrance program according to Global SF Policies, and review and approve the results of external labs.
  • Ensure the knowledge and implementation of Quality SOPS, regulations and guidelines.

COMPLIANCE & REGISTRATIONS:

  • Ensure supplier regulatory listings & record keeping (NDC, IOR, FEIs).
  • Support to QA manager in private certifications (NSF, Kosher.).
  • Cooperate in public and private Audits.
  • Cooperate with Health Authority engagement for understanding requirements to import/sale.

CONTROL OF OPERATIONS:

  • Support to logistics team on the process of importing goods.
  • Participate, support and cooperate with SF Supplier Qualification Program.

SOP AND GUIDANCES MANAGEMENT:

  • Develop, update/review and implementation of standard operating procedures (SOP) for QA department and SF subsidiary according Global rules and local Quality System approved by QA manager.

AUDITS:

  • Monitoring QA aspects of warehousing practices for compliance with warehouse procedure manuals.

INCIDENCE MANAGEMENT:

  • Management of product complaints according to internal procedures.
  • Support for the development of appropriate Corrective and Preventative Actions (CAPAs) and continuous improvement activities.

REPORT & COMUNICATION:

  • Consistently communicates in clear, effective, timely, concise, and organized manner to keeps supervisor and commercial team informed.
  • Maintain the computer systems duly updated (with the quality documents).

TRAINING:

  • Support to QA manager training on GDP/GMP to new employees and development of interdepartmental training plans for technical functions.

Tipo de puesto:
Tiempo completo

Lugar de trabajo:
Empleo presencial