QA Technician, Quality Operations

2 weeks ago

Wilmington, United States Granules Full time
Job DescriptionJob DescriptionDescription:

The QA Technician ensures compliance with cGMP and internal policies, procedures, and specifications. This position is responsible for performing inspections, batch record review, In-process checks, AQL and quality system functions in accordance with cGMP and related company SOP’s, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines.

Requirements:
  • Daily environmental monitoring of cGMP Area, Warehouse, Purified Water at 3701, 3725
  • Affixing Approved Labeling for the released materials & Verification of materials labelling, expiration / retest, quarantine / approved and release status.
  • Verification of dispensing material for the dispensing
  • Line clearance for Type A, Type B for the processing rooms, equipment, and product changeovers
  • Review of Room, Equipment usage logs and make sure the process compliance.
  • Cleaning validation/verification inspections and swab collections and samples submit the quality control.
  • Equipment releases to the operations upon cleaning swab test results received from the Quality Control.
  • Inventory History Record Review and submit to Document control for archives for all the materials and products.
  • Batch Manufacturing Record Review and checklist signoff
  • Conducting an In-process testing as per the batch manufacturing records at various stages like Granulation, Compression, Coating, Encapsulation, imprinting etc.
  • Packaging Lot # Request Initiation based on the requirement.
  • Receipt of the stability Samples as per Inventory History Record “IHR’ and initiate the stability initiation forms to Quality control stability charging.
  • Organizing the retain samples receipt from the contract packagers and record in the log as per the procedures.
  • Retain sample visual inspection and issuance if needed for any testing investigational purposes.
  • Purified water sample Collection & coordinate the samples shipments to the contract testing laboratories.
  • Purified Water test Results review and approve the reports.
  • Managing the environmental monitoring schedules and coordinating with internal departments and external contract testing service providers to make sure the testing is completed as per the schedules.
  • Review and prepare environmental monitoring test results and compilation of the data for the trend reports.
  • Review and approval of Work Orders.
  • Make sure the materials or products are put on Hold as per the notifications.
  • Training for the newly joined QA personnel.
  • Conduct walkthrough inspections to make the compliance.
  • Approve the executed PM & calibration check lists and certificates.
  • Initiation of the quality events as required and participate in writing the investigations related to job functions.
  • Write, revise, and review SOP’s that are related to job function.
  • Any responsibilities assigned by the Manager or Designee

Experience & Education

  • Minimum 2 years of experience in a quality assurance role in a cGMP-regulated environment.
  • Minimum Associates' Degree preferably in sciences (i.e., Biology, Chemistry etc.), Bachelors' preferred
  • Pharmaceutical Manufacturing environment: 2 years
  • Quality assurance in Pharma: 2 years

Knowledge & Skills

  • cGMP compliance within the pharmaceutical manufacturing industry.
  • Writing and maintaining cGMP documentation.
  • Analyze data/information and resolve complex issues.
  • Verbal and written communication skills.
  • Work and communicate with cross-functional teams.
  • Multiple priorities and re-prioritize tasks.

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