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Quality Assurance Compliance Specialist

Nesco Resource

This is a Full-time position in Daytona Beach, FL posted February 20, 2021.

Quality Assurance Compliance Specialist Position:

Responsibilities: Essential Duties

  • Participate in the development and directions of company’s Quality Compliance System to ensure manufacture of products that meet the necessary quality standrads ensuring the quality system’scontinued compliance with all applicable regulatory requirements.
  • Oversee the company risk management program (Annual Reports); provide risk assessment on product nonconformance and field performance issues. Support the company audit program (internal, suppler, customer, and regulatory) to ensure timely and effective corrections to maintain compliance with FDA cGMPs and Quality System Regulations and ISO standards.
  • Support the company supplier management program (ASL, Supplier Quality Agreements) to ensure accurate and compliant supplier file content.
  • Support the company cGMP knowledge management program with HR and Training Department to ensure cGMP proficiency and competency for each worker category. Interface with Manufacturing, Regulatory Affairs, Research &Development, Engineering and other technical disciplines to represent Compliance in project teams, with theobjective to assure that project quality compliance objectives are met.
  • Provide technical recommendation for Management and high level technical personnel regarding product cGMP compliance for projects and/or strategic activities. Provide / formulate recommendations for product disposition or other actions related to product nonconformance and field performance issues.
  • Responsible for performing/supporting quality investigations in a timely and thorough manner per applicable investigation procedures. Development, implementation and establish dashboards, accountability boards and metrics to measure quality function performance.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Additional responsibilities and experience:

  • oversight of audit hosting/response
  • complaint management
  • quality system compliance
  • CAPA trending and oversight

Expertise: Knowledge & Skills

  • Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
  • Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers.
  • Judgement is required in resolving all day-to-day problems.
  • Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.

Responsibilities include:

  • Coordination and response for External Audits, including observation(s) investigation and approval
  • Management of internal audit program
  • Ensure compliance of site Quality Management System, including maintenance of site Quality Policy
  • Evaluate corporate and industry changes for impact to site QMS
  • Presentation of quarterly site Quality System Management Review

Experience required:

  • Lead auditor
  • Root Cause Analysis

Qualifications:
Required:

  • Bachelor’s degree required or equivalent combination of education and experience.
  • 04-06 years related experience required.
  • Applicable industry/professional certification preferred.
  • Regular and predictable attendance
  • Ability to work non-standard schedule as needed

Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.