Loading...
Share this Job
Apply now »

Quality Specialist 1

Your role:

 

The individual performs a variety of tasks within the Quality Assurance department including conducting audits and review / approval of various types of regulated documentation.  Contributes to or impacts the results of the Quality Assurance (QA) team and is accountable for the quality of own work. Receives clear instruction, guidance and direction from more senior level roles or solves problems of low complexity independently by identifying and selecting solutions and by analyzing information. 

  • Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers and other quality records
  • Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis
  • Review and approve validation files for systems and assays
  • Review and approve deviation records
  • Conduct laboratory inspections

 

Who you are:

Minimum Requirements:

  • Bachelor’s degree in a scientific discipline (i.e. Biology, Chemistry, etc.) or technical discipline (i.e. Biomedical Engineering, Biotechnology, etc.)

 

Preferred Requirements:

  • 6+ months experience working within a GxP environment
  • Acts ethically and ensures quality of own work and that of others
  • Takes responsibility for ensuring that turnaround times are met
  • Open-minded, flexible and works with agility 
  • Basic knowledge of FDA regulations (21 CFR Parts 11, 58, 210, 211 etc.)
  • Familiarity with International regulations (EMA, MHRA)
  • Strong oral and written communication and interpersonal skills

 

Job Requisition ID:  210407
Location:  Rockville
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

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.

Apply now »