Quality Assurance Expert 1

1 month ago


Miamisburg, United States JobRialto Full time

Job Summary

Support GMP production by performing batch record issuance, review, correction, release, and retention as well as periodic assessments for production lab compliance.

Support the site's maintenance, development, and improvement of Quality Systems, such as training, CAPA, deviation, change control, and documentation control.

Ensure that all aspects of GMP product release meet analytical, production, packaging, and labeling specifications in accordance with established quality systems.

Support the site's compliance activities through regulatory recordkeeping and reporting.

Key Responsibilities

  • Process Improvement
  • Actively participate in the development, implementation, and improvement of Quality Systems.
  • Routinely support and recommend ongoing process improvements within the department, ensuring efficient and value-added processes.
  • Lead and participate in work with Production, QC, Procurement, Packaging, Maintenance, Customer Service, and Marketing to resolve issues and failures with site products and equipment. Work closely with the site departments to implement process changes based on investigation conclusions.
  • Oversee Trackwise system and aid end users to ensure appropriate entries are made and resolution is achieved in a timely manner.
  • Present various quality system training topics to site personnel when necessary.
  • Identify opportunities for process improvement.
  • Ensure Acceptable Product and Process Consistency
  • Serve as a primary reviewer of executed GMP batch documentation to determine whether process and laboratory results meet the predetermined acceptance criteria for release. Report all process deviations and/or laboratory OOS results. Investigate QA-pertinent process anomalies.
  • Assist in writing, reviewing, or approving GMP Operating Procedures, Validation Protocols/Reports, Master Production Records, Specifications, and other documents for GMP products.
  • Support the Site's Compliance Activities
  • Ensure reports are complete and accurate for HR4You, Trackwise, Mango, and site quality metrics.
  • Ensure appropriate site Quality Assurance personnel are trained as backup for systems role.
  • Facilitate training of other site personnel as required.
  • Follow all safety and quality requirements to complete assigned work.
Required Qualifications
  • Bachelor's degree in Chemistry, Biology, or other Life Science required with 2 or more years GMP-related experience in the chemical, specialty chemical, and/or pharmaceutical industry.


Education: Bachelors Degree

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