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Senior Quality Specialist - 3rd Shift

Company: Alcami Corporation
Location: Durham
Posted on: May 25, 2023

Job Description:

Position Summary

The Senior Quality Specialist is accountable for driving results in a fast-paced environment by effectively performing activities of substantial variety and complexity to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective lab or manufacturing facility.These activities include reviewing documents and data, conducting audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed.The position serves as quality host for client and regulatory agency audits and inspections.The position develops SOPs or other quality documents as needed.The position provides guidance and mentoring for other Quality employees. Serves as a back-up to site Quality Management for technical Quality decision making.The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.This position will work 2nd shift, Monday through Friday.

Essential Functions

  • Serves as Quality host for client and regulatory agency audits and inspections.
  • Serves as back-up to site Quality Management for technical Quality decision making.
  • Performs quality review and approval of complex documents, all types of data, protocols, and/or reports.
  • Performs quality floor audits and/or floor inspections.
  • Provides quality evaluation and release of support materials, products, equipment and facilities as required.
  • Maintains quality databases and may perform analysis and trending.
  • Assists with quality improvement initiatives as needed.
  • Develops quality SOPs or other quality documents and/or reports as needed.
  • Provides consultation on complex quality and compliance topics in areas of expertise.
  • Develops and provides training in quality and compliance topics in areas of expertise.
  • Serves as client quality liaison and/or quality host of client audits; coordinates responses to client audits.
  • Effectively performs a variety of complex duties, on schedule, with accuracy and competency.
  • Maintains accurate files and records.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
    Education and Experience
    • Bachelor's degree in Chemistry, Biology, or relevant field and 5 years of related experience required, or Master's degree in relevant field and 3 years of related experience.
      Alcami Non-Negotiables
      • Consistently demonstrates honesty and integrity through personal example.
      • Follows all safety policies and leads by example a safety first culture.
      • Produces high quality work product with a focus on first time right.
      • Complies with the company code of conduct and policies and regulatory standards.
        Alcami Core Leadership Competencies
        • Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
        • Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
        • Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
        • Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
        • Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
        • Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.
          Functional Competencies
          • Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
          • Good written and oral communication skills.
          • Good math skills.
          • Good computer skills and knowledge of Microsoft Office products.
          • Ability to be trained and to mentor.
          • Ability to act independently.
          • Ability to interact well with clients and regulatory agents.
          • Ability to negotiate.
          • Ability to interact well with employees at all levels.
          • Ability to host audits.
          • Ability to act as technical consultant.
            Decision Making and Supervision Required
            • Uses professional concepts and company policies and SOPs to solve a variety of problems.
            • Receives minimal instruction on day-to-day work, general instructions on new assignments.
              Travel Requirements
              • Up to 5% travel required.
                Physical Demands and Work Environment

                The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear.The employee is frequently required to stand, walk and sit.The employee may be occasionally required to climb or balance.The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration.The noise level in the work environment is usually quiet.The employee may be required to gain access to lab, or manufacturing areas for inspections or work discussions.The noise level in these additional work areas may be louder. The employee is required to wear the appropriate personal protective equipment to perform the job duties.Such personal protective equipment may include but is not limited to:safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

                Other Duties

                Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Keywords: Alcami Corporation, Durham , Senior Quality Specialist - 3rd Shift, Other , Durham, North Carolina

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