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cGMP Engineer

Company: Yoh
Location: Bessemer City
Posted on: September 19, 2023

Job Description:

Responsibilities:-- As a cGMP Quality Engineer, you will work with cross functional teams, such as Manufacturing, Quality, Regulatory and R&D, to ensure the Pharmaceutical Lithium Carbonate process remains compliant with cGMP and FDA regulations. You will provide support for:--

  • Perform batch analytical record review and prepare documentation for lot disposition by management as required
  • Develops/Uses Key Process Indicators and statistical methods to determine process effectiveness, identify areas for improvement, best practices, and lead teams in driving continuous quality improvement
  • Maintains records of raw materials and packaging; analytical testing and COAs
  • Leads/Drives/Supports corrective and preventive actions, and effectiveness verification activities for product quality issues and customer complaints
  • Ensures that quality reporting and GMP records, such as Batch Records, QC Data, etc. are completed accurately and timely
  • Review and approve quality events including planned and unplanned deviations, OOS and OOT
  • Lead in closing GMP gaps from internal and external audits
  • Ensure training records are maintained and up to date
  • Ensure GMP files are up to date and filed accordingly to document retention policy
  • Maintain the Pharm Carb retention samples through annual audits
  • Support the development and sustainability of key cGMP and FDA documents such as Annual Reviews, Drug Master File, Validations, etc.
  • Conduct internal audits and other quality system functions as assigned.
  • Support regulatory and customer audits
  • Ensure that all company safety rules and regulations are followed and promote general plant safetyYou will report to the site Quality Program Manager and you will be based at the Bessemer City plant. Your role will support the Pharmaceutical Lithium Carbonate process.--Required Education:-- Bachelor's Degree in a science-related field (Chemical Engineering preferred)Qualifications:--
    • 3+ years' experience in an FDA regulated process, pharmaceutical manufacturing a plus
    • 5+ years' experience in a manufacturing environment with strong experience in product quality; chemical manufacturing a plus
    • Knowledge of ISO 9001:2015 is required
    • Knowledge of cGMP is required
    • Awareness of, or training in, ICHQ7 guidelines is required
    • Experienced professional with developing knowledge of the technical field and working knowledge of business processes, technologies and applications.
    • Can independently select, evaluate and apply techniques, processes and criteria to complete standard assignments
    • Competency at the customer interface level commensurate with starting level.
    • Strong safety orientation in OSHA--
    • Knowledge of Statistical tools such as Minitab or equivalent
    • The ability to effectively present at both informal and formal settings
    • Ability to lead project teams
    • Data based and results driven with strong action orientation combined with practiced risk management abilities
    • Strategic agility with foresight and the ability to create alternate plansNote: Any pay ranges displayed are estimations.-- Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.-- All qualified applicants are welcome to apply.Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Visit--to contact us if you are an individual with a disability and require accommodation in the application process.

Keywords: Yoh, Gastonia , cGMP Engineer, Engineering , Bessemer City, North Carolina

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