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Associate Quality Specialist - manufacturing, batch record review in Mangum, NC at Apex Life Sciences

Date Posted: 12/3/2018

Job Snapshot

Job Description


Responsibilities:

  • Provides direct batch record review support to the Vaccine Manufacturing Facility
  • Responsible for the review of documentation associated with final filled material
  • Execute review of electronic Batch Records (EBRs) utilizing reduced content review of critical steps and parameters as applicable
  • Work with Operations Technical Support Team and Coaches to resolve issues identified during document review
  • Participate in process improvement or learning events, as guided or approved by Quality management
  • Direct support of project activities and all other associated Quality functions
  • Other duties as requested by Management

Qualifications:

  • Bachelor's degree 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.
  • 1+ years of relevant work experience in a 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. 
  • Familiarity with vaccine and/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.
  • Familiarity with computer systems (SAP, LIMS, electronic batch records) is a plus

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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