QA Engineer

8/3/22

Charles City, IA

1780

1780 QA Engineer

Overview

The QA Cleaning Engineer is responsible for providing Quality Assurance oversight to all site equipment and facility Cleaning Activities to mitigate cleaning-related regulatory risks at CCC. This position will function as site QA Subject Matter Expert as the leader of an inter-disciplinary team responsible for equipment and facilities cleaning, cleaning procedure development, cleaning process execution and improvement and completion of cleaning verification and cleaning validation studies. Under the direction of site management and cooperation with other disciplines (as Production, Process Engineering, Project Engineering, Analytical Development, etc.) will ensure appropriate cleaning validation studies are completed in accordance with cGMP requirements, industry standards and customer expectations. In additional This position also provide technical review and approval for cleaning-related investigations (OOS and Deviations) and projects including review and approval of cleaning validation protocols and reports, cleaning procedure(s), assist in conducting cleaning-related investigations, root cause analyses and CAPA development, review, approval and effectiveness check(s).

Responsibilities

  • Serve as site Quality Assurance cleaning Subject Matter Expert and serve as leader of an inter-disciplinary team responsible for equipment and facilities cleaning, cleaning procedure development, cleaning process execution and improvement and completion of cleaning verification and cleaning validation studies.
  • In cooperation and coordination with other departments, develop and implement cleaning approaches and strategies that ultimately result in completion of cleaning validations studies that comply with regulatory expectations, API manufacturing industry standards and customer expectations
  • Assist in development, implementation and refinement and reporting of cleaning-related metrics. Assist in development of program timelines with milestones and report progress to senior management. Work across departments to meet project timelines by adjusting resources and priorities
  • Liaise with clients, customers and regulatory authorities regarding site equipment and facility cleaning programs, including cleaning verification and cleaning validation. customer support person to answer, address and/or compile relevant data to support including, but not limited to:
    • Respond to cleaning-related inquiries and questions
    • Review and respond (develop CAPA) to customer inquiries and audit observations
    • Provide Standard statements of compliance
  • Write, review and approve cleaning-related procedures and documents as cleaning procedures/records, cleaning SOPs and validation protocols and reports
  • Provide technical assistance with conducting cleaning-related investigations and writing and issuance of investigation reports. Provide risk-based analyses regarding product and validation impact assessments.
  • Assist in developing cleaning-related corrective actions, preventive actions and assess in assessing CAPA effectiveness.
  • Review of various change controls for impact to the global CCC cleaning and cleaning validation program. Assess changes for impact to equipment cleaning and cleanability, ability to perform cleanliness inspections, swabbing and testing
  • All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
  • Assist in development of cleaning-related

Qualifications

  • University degree (or equivalent) as BA or BS in chemistry, engineering or other scientifically relevant field (i.e. industrial hygiene, pharmacy, etc.)
  • 5+ years of relevant experience working in commercial pharmaceutical manufacturing cGMP environment. Operational understanding of manufacturing equipment function and operation
  • Strong critical thinking skills
  • Strong interpersonal and leadership skills, including initiative and strong work ethic.
  • Ability to effectively lead inter-disciplinary team of personnel responsible for equipment and facilities cleaning, cleaning procedure development, cleaning process execution and improvement and completion of cleaning verification and cleaning validation studies.
  • Extensive experience working in manufacturing environment and approve cleaning procedures and documents
  • Knowledgeable in technical aspects of cleaning including cleaning procedures and practices, cleaning validation strategies (including grouping), performing risk analyses land able to assist in performing cleaning-related investigations

Apply Now