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Specialist, Quality

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About the position

Responsibilities

  • Perform 100% audit of process documents/log books to ensure completeness and accuracy for assigned functional area.
  • Provide coaching and mentoring of Operations personnel regarding documentation completion.
  • Coordinate with Operations to discuss, resolve, and eliminate documentation observations.
  • Conduct GMP walk-through inspections of assigned departments to ensure compliance with cGMPs and regulatory requirements.
  • Ensure proper identification of release status and control of materials through maintenance of quarantines in the SAP system.
  • Perform Quality review/approval of new and updated SOPs and CJAs.
  • Assist with training of incoming personnel and ensure compliance with departmental procedures.
  • Participate in departmental communication processes to escalate concerns and best practices.
  • Collaborate with members from other support groups to identify and implement continuous improvement initiatives.
  • Resolve outstanding issues with process documents/log books and GMP walk-through inspection observations.
  • Cross-train to support other functional quality areas including deviation management and inspection support.
  • Complete training to review qualification documents, change requests, and atypical event investigations.
  • Prioritize review of process documents/log books to maximize cycle-time efficiency.
  • Perform SAP transactions required to document Batch Record and Critical Site review.

Requirements

  • Bachelor degree in a scientific or engineering field preferred; candidates with other majors will be considered with relevant experience.
  • At least one year of relevant post-degree work experience in a GMP-related field, including Technical, Engineering, Quality, or Operations.
  • Evidence of leadership skills with good verbal and written communication skills.
  • Effectiveness and creativity in solving technical problems.
  • Attention to detail, flexibility, and awareness of production and quality control problems.
  • Basic understanding of cGMPs and regulatory requirements in the pharmaceutical field.
  • Basic understanding of Microsoft applications (e.g., MS Excel, Outlook, MS Access).
  • Flexibility to support off-shift or weekend schedules, if necessary.

Nice-to-haves

  • Familiarity with vaccine and/or pharmaceutical processing.
  • Experience with manufacturing batch records is strongly preferred.
  • Quality assurance audits or inspection experience in vaccine or pharmaceutical manufacturing is a strong plus.
  • Aseptic gowning experience.

Benefits

  • Health insurance coverage
  • Dental insurance coverage
  • 401k retirement savings plan
  • Paid holidays
  • Flexible scheduling options
  • Professional development opportunities
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