Jobs

Quality Assurance Specialist (Nebulizer)

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Location
Monroe, NC
Salary
$45,000 - $65,000
Job Type
Direct Hire
Degree
Bachelor of Science
Date
Jan 11, 2019
Job ID
2650522

We are looking for a Quality Assurance Specialist, In Process (Nebulizer). This position will be responsible for working closely with the Nebulizer Operations organization supporting production preparation (e.g., line clearances) and in process activities during compounding through packaging. Responsibilities within SAP will include raw material and batch release. Responsibilities within MasterControl will include Documents, Incidents, CAPA, and Change Control activities.

Responsibilities include but are not limited to:

  • Support quality system controls to ensure state of compliance and patient safety
  • Perform "on the floor" Quality oversight during manufacturing operations and assist Production personnel with troubleshooting in an Aseptic environment
  • Perform regularly scheduled and as needed compliance walkthroughs in Production and Warehouse
  • Perform line clearance and approval for use of areas/rooms for Dispensing, Sampling, Manufacturing and Packaging
  • Assure Quality approval and release of raw materials and components prior to manufacturing
  • Assist in control of product labels
  • Assist in maintaining reserve sample storage.
  • Provide Quality support during In-Process Sampling, Validation, Cleaning Verification, activities, etc.
  • Perform timely Batch Record Review
  • Initiate and assist in completion of Incidents, CAPA and Change Control, as needed
  • Write and review Standard Operating Procedures (SOPs), Forms, Batch Production Records, Protocols, as needed
  • Support regulatory inspections and audits
  • Communicate results from Compliance walkthroughs
  • Perform problem-solving activities
  • Ensure Production and Warehouse activities are performed in a compliant manner with SOPs
  • Aid in the identification of Process Improvements on a continuous basis
  • Aid in the monitoring of Key Performance Indicating (KPIs) for functional area and ensure systems are operating within target

Education:

  • Minimum Bachelor’s degree in scientific discipline or closely related technical field of study.

Experience:

  • Minimum combined five (5) years of pharmaceutical experience in a Manufacturing or Quality role
  • Previous experience on the floor in Production (Compounding, Filtration, Filling, Packaging, etc.) in an Aseptic environment is required
  • Working knowledge of Lean, Six Sigma, 5S is desirable

Knowledge & Skills:

  • Proactive, results oriented, and a strong attention to detail
  • Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team
  • Strong organizational, analytical, and problem-solving skills
  • Ability to analyze details and perform structured decision-making
  • Ability to read, write, and speak English
  • Excellent verbal and written communication
  • Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc.
  • Knowledge of MasterControl or other electronic document system
  • Knowledge of SAP (Systems, Applications & Products in Data Processing) or similar ERP system
  • Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast-paced critical work environment
  • Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner
  • Quality certifications (e.g., ASQ Auditor) a plus

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