Associate Quality Specialist in West Point, PA at Apex Life Sciences

Date Posted: 5/16/2018

Job Snapshot

Job Description


Responsibilities:

  • Provides direct Quality support to a production area as part of a Quality 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 and 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.
  • 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).
  • 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 team 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.

Qualifications:

  • Bachelor's degree in an appropriate scientific or engineering field preferred
  • 1+ years of relevant post-degree work experience in a laboratory, manufacturing, or quality position
  • Familiarity with vaccine or pharmaceutical processing desired
  • 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 is a plus
  • Evidence of good oral and written communication skills, including 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.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.