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Quality Specialist II

Your Role:

The scope of this individual contributor position within the US Biologics Quality Assurance department includes influence and impact within QA and across a variety of operations departments regarding GXP compliance.

Responsibilities for this position will include but are not limited to: Review quality records/documents and conducts inspections, as assigned, for compliance requirements; Interact with other departments to ensure compliance with internal procedures and FDA regulations; Review assay data, protocols, reports, technical specifications, certificates of analysis, RIRs, Cell banking Production Records for compliance requirements; Review lab records, batch records, SOPs and other documents for auditing requirements; Audit routine assays; Conduct Systems Inspections and In-Process Inspections; Review and approve deviation records.


Who You Are:

Minimum Qualifications:

  • Bachelor of Science Degree in Biology, Chemistry, or other Science or Technical discipline
  • 1+ years’ experience working in Quality Assurance or within a GXP environment
  • 1+ years’ experience working with FDA regulations (cGMP, GLP, Part 11)


Preferred Qualifications:

  • Working knowledge of good documentation practices
  • Good oral, written communication and interpersonal skills required
Job Requisition ID:  195861
Location:  Rockville
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Job Segment: QA, Quality Assurance, Quality, Technology

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