West Point, PA
1+ Year Contract
- The Contractor Quality Specialist (CQS) provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model.
- The CQS, with guidance from the IPT Quality Leadership team, ensures product / process quality and performs activities to facilitate the release of product to the marketplace.
- The CQS performs 100% process document / log book audits for accuracy and completeness and works closely with the assigned End to End (E2E) in a team environment to ensure timely review and documentation is done right first time.
- The Contractor Quality Specialist will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas in compliance and will train on and gain competency in activities to facilitate release of product for assigned End to End (E2E).
- Performs 100% audit of process documents / log books to ensure completeness and accuracy for assigned End to End (E2E).
- Maintains any tracking databases and logs associated with this review.
- Coordinates with Production to discuss, resolve, and eliminate documentation observations.
- Actively participates in the Tier process and uses this forum to escalate concerns and best practices.
- Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans.
- Prioritizes review of process documents / log books in order to maximize cycle-time efficiency.
- Performs SAP transactions required to document Batch Record review.
- Bachelor's degree.
- Technical emphasis in an appropriate scientific or engineering field preferred; candidates with majors in other fields will be considered if accompanied by significant relevant experience.
- At least one 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 and Skills:
- 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