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Quality Associate - Environmental Monitoring in Lansdale, PA at Apex Life Sciences

Date Posted: 12/7/2018

Job Snapshot

Job Description


Responsibilities:

  • Provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model.
  • Ensures product / process quality and performs activities to facilitate the release of product to the marketplace.
  • Responsible for the review and evaluation of routine and per process environmental monitoring (EM) sampling of classified areas and utilities.
  • Works closely with the assigned End to End (E2E) in a team environment to ensure timely completion of responsibilities with emphasis on right first time.
  • 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 (E2E).
  • 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

Qualifications:

  • Bachelor's degree in Microbiology, Biology, or related is preferred. BS in Chemistry, Engineering, Pharmacy, or equivalent will be considered with relevant experience in environmental monitoring, laboratory operations, or sterile/vaccine production setting. 
  • 1+ year of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations.
  • Basic understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical or related fields desired
  • 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.

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 844-463-6178.




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