Senior Technical Operations Validation Specialist

Jackson Healthcare-posted 2 months ago
Senior
Bristol, TN
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies. We’re always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence. The Senior Technical Operations Validation Specialist is the subject matter expert (SME) for various types of technical responsibilities which are within the scope and oversight of the pharmaceutical quality unit, encompassing validation of processes, equipment, facilities, cleaning procedures, and computerized systems; commercial support, and research and development support as needed. Establishes that all computerized systems are functioning as intended and designed. Ensures that all written procedures and practices are in place for computerized systems and serves as primary support for QC and Technical Support laboratories for analytical method development, problem solving and validation in addition to leading equipment validation.

  • Create validation protocols for processes, equipment (IQ, OQ, and PQ), cleaning procedures, facilities, and computerized systems.
  • Serve as system administrator and technical SME responsible for ensuring systems are qualified and functioning as intended.
  • Ensure process flow of tasks are well designed and efficient, and systems are compliant with regulatory and corporate standards for data integrity.
  • Provide primary technical support for QC laboratories for analytical method development, problem-solving, and validation.
  • Configure and test software such as Quality Control Laboratory Information Management System (LIMS), Chromatography Data System (CDS) and other QC computerized systems.
  • Prepare and compile data to analyze test information to determine process or equipment operating efficiency.
  • Support risk assessments for any product quality inquiries and calculations of formulation content.
  • Liaise with laboratory section managers and other QC personnel, IT and service providers to support questions and resolve problems.
  • Support technical documentation for CMC supplements, Annual Reports, and Annual Product Reviews.
  • Assist with evaluation and implementation and validation of identified software for new applications.
  • Notify lab personnel of any operational challenges or hardware/software system failures.
  • Set up/modify product specifications, test methods, calculations per methods and perform test runs in LIMS and SAP.
  • Recommend improvements, ideas or changes to methods and operations for cGMP compliance.
  • Assist with technical writing, e.g., revision of analytical procedures, equipment related SOPs, and results summaries.
  • Keep current with technical and professional literature and compendia.
  • Encourage safety first in work practices via guidance from training sessions and other resources.
  • Perform statistical analysis of laboratory and process data to support Annual Product Reviews and Continued Process Verification programs.
  • Technical writing skills, including validation protocols, risk assessments, and SOPs in a FDA-regulated environment.
  • Problem solving skills.
  • Ability to perform independent research to provide scientific and technical justification for proposed procedures.
  • Data analysis skills, including statistical analysis of process and laboratory data.
  • Strong computer skills, including word processing, spreadsheets, and application software.
  • Experience with SAP and related laboratory software.
  • Knowledge of analytical methodologies and instrumentation.
  • Recent relevant experience with regulatory expectations for appropriate data analysis.
  • Equal Opportunity Employer
  • Commitment to diversity and inclusion.
Track Jobs with Teal

Job Search Resources

•
AI Resume Builder
•
Validation Engineer Resume Examples
•
Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service