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Sr. Audit Specialist (Biotech)

Lynkx Staffing

Sr. Audit Specialist (Biotech)

Saddle Brook, NJ
Full Time
Paid
  • Responsibilities

    Our biotechnology client is seeking a Senior Audit Specialist. The incumbent is primary responsible for supporting the management of the inspection / audit program, leading the internal audit of areas to be inspected, and manage the preparatory steps for a periodic Management Review. This role will report to the Associate Director of Quality and will support Quality Management with department, organizational, and operational excellence initiatives. The Sr. Audit/Audit Specialist exercises independent judgement, within defined role, practices, and policies, when selecting methods, tools, and techniques for obtaining solutions.

    • Below is the summary of the role responsibilities. This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.
    • Act as key contact point to prepare and ensure follow-up of audits and inspections, but not limited to, inspection/PAI readiness planning, scheduling, managing audit resources, running audit front room, ensuring front and back room is supported through audit, defining support needed, and ensuring training is provided. Coordinate all aspects of the preparatory steps of an audit/inspection.
    • Develop and maintain inspection/audit readiness tool in partnership with Minaris RM Quality Network in the North America region.
    • Liaise with relevant functional areas and / or appropriate stakeholders to document audit responses and to elaborate compliant CAPAs: propose CAPAs, ensure and guarantee that CAPAs will address the compliance situation.
    • Review and provide guidance for the audit CAPA to ensure appropriate CAPA are generated to increase compliance, increase efficiency and productivity, and prevent repeat occurrence of audit findings/observations. Assure monitoring of audit CAPAs and organize CAPA Effectiveness Review, when appropriate.
    • Conduct periodic status update meetings with cross functional departments and other stakeholders to ensure timely closure of audit CAPA / commitments to the clients / regulatory agency.
    • Responsible for the Minaris internal audit program that includes, but not limited to, leading the internal audit of areas to be inspected based on Audit Schedule, identifying and training colleagues to participate on audit team, outlining observations and clearly communicating to stakeholders, and preparing the internal audit documentations. 
    • Support the management review process that includes, but not limited to, facilitation of management review preparation meetings, capturing of discussions and action items, and preparing the management review report / document.
    • Support Quality Management with department, organizational, and operational excellence initiatives.
    • Actively participate in the development of Minaris Policies and Procedures.
    • Fosters Quality culture and mindset with regards to Inspection Readiness, Management of Audit CAPAs, and Management Reviews.
    • Provide training on specific GXP requirements and inspection readiness & preparedness related activities.
    • Coordinate all aspects of the preparatory steps for a periodic Management Review and to ensure support is provided to appropriate management review of all quality and compliance related topics including the review of Key Quality Indicators. Support the implementation of the appropriate continuous improvement initiatives for quality and compliance related areas when required.
    • Share best practices and lessons learned following inspections/audits

    REQUIREMENTS

    • Minimum of 5 years of relevant experience with applicable clinical or commercial regulated environment.
    • Knowledge of FDA and EMEA/MHRA regulations.
    • Understanding of quality system applications, including the change control, training, deviations, CAPA management, internal and external audit, etc.
    • Experience in authoring, reviewing, and /or approving cGMP related documents (e.g., change control, CAPA, investigation, technical documents, procedures, etc.)
    • Experience in working in teams.
    • Experience participating in health authority inspections and/or client audits.
    • Understand requirements pertaining to aseptic manufacture of cellular products.
    • Ability to work effectively with clients in a contract manufacturing environment.
    • Strong written and oral communication skills. Capable to communicate in English.
    • Ability to think strategically and tactically (detail-oriented)
    • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
    • Analytical and problem-solving skills
    • Strong written and oral communication skills
    • Meeting management/facilitation skills/teamwork
    • Ability to multi-task is essential
    • Flexible and able to adapt to company growth and evolving responsibilities.
    • Ability to effectively interface with peer group in the company and work collaboratively to achieve company goals.
    • Collaborates with other team members and demonstrates outstanding interpersonal skills.
    • Ability to work autonomously in an entrepreneurial, fast paced environment.
    • Must have the ability to work in a team-oriented environment and with clients
    • Must be able to work during the weekend, holidays and as required by the company
    • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens

    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.