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Quality Assurance Associate

4 months ago

Chandler, United States Tailstorm Health Inc. Full time
Job DescriptionJob DescriptionDescription:

Medivant Healthcare is a new fully automated injectable manufacturing & outsourcing (503B) facility based in Phoenix, AZ. The company manufactures single dose liquid injectable vials for sales to hospitals around the country. Company focuses on molecules and products that are on FDA’s shortage list. Current molecules being sold to hospitals are Sterile water, Sodium Chloride, Lidocaine, Bupivacaine and a few more. Company will be expanding its range to 15 molecules by end of the year.

  • Schedule: F/T: Monday through Friday, more details upon interview
  • Benefits: Health, Dental, Vision, LTD, STD, Accident, Life
  • Salary: $45,000 to $70,000

The Quality Assurance Associate is responsible for management of routine quality assurance needs associated with manufacturing and testing of raw materials and finished pharmaceuticals, quality system maintenance and improvement initiatives, and compliance to GMP quality and regulatory standards. Serves as first responder for Manufacturing, Packaging, or Laboratory deviations. Works closely with the Manufacturing, and Laboratory Management to assure the appropriate immediate actions and corrective actions are taken for deviations and as a resource to production regarding quality issues.

Essential Functions

  • Works with the Quality Assurance Manger to identify routine and specific work assignments and priorities.
  • Assist QA Manager and Director in assessing and responding to product related complaints, investigations/deviations and in the preparation of Annual Product Reviews (APRs).
  • Ensures the thoroughness and timely completion of investigations of deviations and Change Controls
  • Trains site personnel on cGMP, SOP’s and Work Instructions.
  • Reviews, verifies and documents all activities on appropriate forms or in the batch record for accuracy and completion.
  • Issues batch records and associated forms to production as needed.
  • Creates and issues labels for drug product to production as needed.
  • Ensures compliance to the Annual Stability schedule through the collection of stability samples and initiation of stability studies.
  • Ensures compliance to Annual Cleaning Verification Program. Collects rinse samples for cleaning validation studies.
  • Coordinates with other functional departments (such as Manufacturing and QC) for process validation and test batches.
  • Collects samples at various stages for process validation studies.
  • Maintains inventory records and reports of Finished Product Retain samples.
  • Dispositions raw materials, labeling materials, and finished drug products in ERP system.
  • Assists Production and Warehouse personnel in updating inventory levels as a result of sampling, testing, or deviations.
  • Monitors the reduced testing of materials and in-process testing on drug products and ensures adequate coverage to meet operational objectives.
  • Notifies production operators and supervision immediately of any problems with in-process testing results.
  • Communicates quality failures and other critical product concerns to QA Manager in a timely manner.
Requirements:
  • Bachelor’s degree with a technical (science) major.
  • Three (3) years of pharmaceutical QA experience preferred.
  • Demonstrated quality experience in batch record review, disposition, manufacturing, investigations and CAPA.
  • Knowledge and experience of applicable FDA regulatory standards and requirements for aseptic manufacturing required. Knowledge and experience in root-cause investigations and CAPA implementation. Knowledgeable of GMP SOPs, controlled documents and master documents including labeling.
  • Basic knowledge of computers using MS Office, MS Outlook and business software systems commonly used in the pharmaceutical industry such as SAP required.
  • Ability to add, subtract, multiply and divide in all units of measure using whole numbers and decimals. Must be able to use conversion factors involving metric and US measures and interpret data from tables and charts.