Specialist, Quality
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
