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Quality Specialist - I (Assistant)
Ref No.: 17-15424
Location: WEST POINT, Pennsylvania
The Environmental Monitoring Quality Specialist (CQEMS) provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model. The CQEMS, 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 CQEMS is responsible for the review and evaluation of routine and per process environmental monitoring (EM) sampling of classified areas. The CQEMS is responsible for reviewing batch records. This position also works closely with the assigned End to End in a team environment to ensure timely completion of responsibilities with emphasis on right first time. The CQEMS will become knowledgeable in Federal and other regulatory agency requirements and GMPs to assure that all areas operate in a state of compliance, and will train on and gain competency in their responsibilities for assigned End to End. Specific responsibilities include but are not limited to the following: • Monitor environmental performance against specifications within classified areas. • Provide environmental support to manufacturing and testing areas as needed. • 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. • Adherence to SOPs, GMPs and safety procedures. • Perform investigations into environmental excursions. • Author environmental project protocols and reports • Provide shop floor quality presence.

Quals--
Education: • Bachelor's degree in Microbiology or Biology is preferred. Candidates with BS in Chemistry, Engineering, Pharmacy, or equivalent will be considered with relevant experience in environmental monitoring, laboratory operations, or sterile/vaccine production setting. Required Experience and Skills: • At least one year of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations. • 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 vaccine, sterile pharmaceutical or related fields. • Experience in batch record review.