Quality Specialist (Batch Record Review/Release)

Full Time
La Vergne, TN 37086
Posted
Job description

What Quality Control contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Control is responsible for the analysis or inspection of materials, components, products or processes for compliance with specifications and standards.

Job Summary
The primary responsibility of a Quality Specialist is to work closely with the Cardial Health Packaging Solutions (CHPS) team to create batch records, work closely with QA management and Operation team in assisting with investigations, assists in leading the internal audit program, monitor the calibration program, review and release batch records.

Responsibilities

  • Archiving released batch records.
  • Applies Good Manufacturing Principles in all areas of responsibility and ensures compliance across the facility.
  • Drives quality and productivity to meet Customer delivery requirements and financial commitments.
  • Participate in Investigations. Works closely with Operations and QA Management to document investigation and deviation reports as needed. Works closely with QA Management in maintaining the CAPA system.
  • Provide CAPA follow-ups.
  • Build relationships with key supplier contacts.
  • In partnership with quality management, leads processes driving on-going continuous improvement of Customer satisfaction, compliance, safety, and quality.
  • Assist in the creation/execution of work instructions, SOPs, forms, etc.
  • Assist in serialization operations such as verifying orders in the warehouse management system (WMS) and sending orders to the designated serialization line.
  • Assist in the brainstorming/creation of deviation reports for nonconforming events as needed.
  • Perform environmental monitoring according to CHPS procedures.
  • Perform other miscellaneous duties as assigned by management.


Qualifications

  • High School diploma or equivalent experience in related field preferred
  • 0-2 years of experience preferred
  • Proficient computer skills including MS Office and spreadsheets.
  • Organized, detail oriented and possess ability to multi-task
  • Strong written and verbal communication skills to effectively communicate with internal staff, management, and suppliers.
  • Ability to adapt quickly, work under pressure, and prioritize workload in a fast paced and constantly changing environment.


What is expected of you and others at this level

  • Applies basic concepts, principles and technical capabilities to perform routine tasks
  • Works on projects of limited scope and complexity
  • Follows established procedures to resolve readily identifiable technical problems
  • Works under direct supervision and receives detailed instructions
  • Develops competence by performing structured work assignments

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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