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Job Overview

  • Company: Medix
  • Employee Type: Full-Time
  • Industry: Pharmaceutical
    Manufacturing
  • Job Type: Pharmaceutical
    Manufacturing
    QA - Quality Control
  • Location:


QA Specialist- Pharmaceutical

Job Description

QA Specialist-Pharmaceutical

ESSENTIAL JOB FUNCTIONS
  1. Performs investigations of non-conformance including customer and consumer complaints and tracks resulting CAPA action plans.
  2. Conducts cGMP training and maintains training records.
  3. Administers the product stability program and designs compliant bracketing and matrix strategies for stability profiles.
  4. Administers the cGMP compliance audit program.
  5. Develops and maintains SOPs and forms governing areas of responsibility.
  6. Acts as a liaison with raw material manufacturers and suppliers ensuring compliance with company and regulatory requirements.
  7. Assists Manager, Quality Assurance in administering the Quality Management Software.
  8. Monitors regulatory and industry trends/actions and reports regularly to Quality management.
  9. Develops and maintains performance measurements for areas of responsibility.
  10. Performs and assumes other duties and responsibilities, as may be required by the Manager, Quality Assurance and/or Director, Quality.

 

 

EDUCATION AND EXPERIENCE
  1. A 4-year college degree in the sciences or related discipline; or equivalent in knowledge and training.
  2. The knowledge and skills required for this position are typically acquired in 3 to 5 years of experience in a pharmaceutical manufacturing environment.
  3. Effective interpersonal skills to interact with various levels of internal and external customers and suppliers.
  4. Must possess comprehensive understanding of cGMP regulations, Standard Operating Procedures (SOPs), and quality assurance policies and procedures (e.g., perform receipt inspection, batch record issuance, and finished product release duties, etc.).
  5. Thorough knowledge of auditing programs.
  6. Thorough knowledge of stability programs.
  7. Computer literate in a Windows environment.
  8. Establishes priorities and works independently on a multitude of concurrent tasks with little supervision.
  9. Detail-oriented and prepares comprehensive and accurate documentation.
  10. Good math aptitude including statistical analysis.
  11. Good organizational ability.
  12. Accepts other duties, as assigned.
  13. Discreet with confidential information to which he/she has access.
  14. Develops and maintains effective working relationships with internal and external customers and suppliers, functions as a team player, accepts constructive criticism from management, and complies with Company policies.


Job Requirements

Requirements:
3-5 Years in Pharmaceutical manufacturing
Bachelor Degree

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  • QA Specialist- Pharmaceutical @ Medix