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Validation Specialist

Department: Validation
Location: West Columbia, SC


Position Summary:

  • Perform and oversee qualification and validation activities.
  • Assists with additional work duties or responsibilities as evident or required.
  • Performs other duties as assigned or apparent.

Primary Accountabilities:

    • Write installation, operational and performance qualification protocols for production equipment, laboratories (Micro & Chemist) and production processes as required. Write new Standard Operating Procedures.
    • Execute and/or coordinate execution of validation protocols with R&D engineers, engineering personnel, quality assurance and/or (Micro & Chemist) laboratories. Write summary reports for the completed qualifications including recommendations for process improvements. Perform statistical analysis.
    • Oversee calibration activities. Approve in-house and outside calibration raw data and certificates. Perform statistical analysis.
    • Provide support to Validation Manager to complete validation activities and keep company in FDA compliance.

Knowledge, Skills & Abilities:
NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbentsí performance objectives as outlined by the incumbentsí immediate supervisor or manager.

  • Bachelorís Degree in Science or Engineering (4 year) from regionally accredited university or Associate Arts Degree (2 year) and 3 plus years of relevant experience.
  • Work experience in clean room. Need to have cGMP knowledge. Must follow SOP, calibration test methods and validation protocols.
  • Microsoft Word, Power Point, Excel, Access. Good communication and interpersonal skills. Organizational Skills. 
  • Specific expertise, skills and knowledge within quality assurance gained through education and experience.
  • The ability to take strategic objectives and accept accountability to drive results through effective actions.
  • The ability and willingness to change direction and focus to meet shifting organizational and business demands.
  • The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
  • The ability to take strategic objectives and accept accountability, motivate and influence others thinks globally and leverages diversity.
  • The ability to manage a multitude of resources and to be accurate and current with data and information.
  • Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (60%), walking, and hearing.

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