Quality Specialist I

3 weeks ago


Lansdale, Pennsylvania, United States On-Board Companies Full time
Job Title: Quality Specialist I

About the Role:
On-Board Companies is seeking a Quality Specialist I to join our team in West Point, PA. As a Quality Specialist I, you will provide direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model. With guidance from the IPT Quality Leadership team, you will ensure product / process quality and perform activities to facilitate the release of product to the marketplace.

Key Responsibilities:
• Perform 100% audit of process documents to ensure completeness and accuracy for assigned End to End (E2E).
• Maintain any tracking databases and logs associated with this review.
• Coordinate with Production to discuss, resolve, and eliminate documentation observations.
• Actively participate in the Tier process and use this forum to escalate concerns and best practices.
• Collaborate with IPT members in the identification and implementation of continuous improvement initiatives and action plans.
• Prioritize review of process documents in order to maximize cycle-time efficiency.
• Perform SAP transactions required to document Batch Record review.

Requirements:
• Minimum 1 year of relevant post-degree work experience in a laboratory, manufacturing, or quality position.
• Evidence of good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
• Attention to detail, flexibility and an awareness of production and attendant quality control problems.
• Basic understanding of GMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.

Preferred Experience:
• Familiarity with vaccine and/or pharmaceutical processing.
• Familiarity with manufacturing batch records is a key skill necessary for success in this position; prior batch record experience is a strong plus.
• Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is beneficial.
• Familiarity with computer systems (SAP, LIMS, electronic batch records) is a plus.

About On-Board Companies:
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics. We are a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.

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