Assistant Quality Specialist - audits, SAP in Lansdale, PA at Apex Life Sciences

Date Posted: 3/13/2018

Job Snapshot

Job Description


  • Provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model.
  • Ensures product and process quality and performs activities to facilitate the release of product to the marketplace.
  • Performs 100% process document review for accuracy and completeness and works closely in a team environment to ensure timely review and documentation is done right first time. 
  • Performs 100% audit of process documents 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 in order to maximize cycle-time efficiency. 
  • Performs SAP transactions required to document Batch Record review


  • Bachelor's degree required with a 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.
  • Familiarity with vaccine and/or pharmaceutical processing desired 
  • 1+ year of relevant post-degree work experience in a laboratory, manufacturing, or quality position required
  • 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. 
  • 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 such as SAP, LIMS, electronic batch records a plus

***For immediate consideration, please email your updated resume to with 'Assistant Quality Specialist' in the subject line.