Offers “Merckgroup”

days ago Merckgroup

Quality Specialist 2

  • Internship
  • Rockville (Clarke County)
  • Sales

Job description

Quality Specialist 2

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.


Responsibilities include but are not limited to: 

·  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 minor, major and critical impact deviations / OOS records
·  Conduct trend analysis for deviations and review / approve applicable CAPA records
·  Provide support for client regulatory submissions, client audits and supplier audits
·  Review and approve client and supplier quality agreements


Who you are:

Minimum Qualifications:

·  Bachelor’s degree in scientific field (i.e. Biology, Biotechnology, etc.) or technical field (i.e. Engineering, etc.) with 2+ years' experience in Quality Assurance or related field within a GxP environment


Preferred Qualifications:

·  Acts ethically and ensures quality of own work and that of others
·  Takes responsibility for ensuring that turnaround times are met
·  Works with cross-functional teams and builds networks within QA and Operations departments
·  Collaborates with various teams to identify and implement improvements
·  Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity)
·  Fully qualified to independently perform two or more of the following specialty areas at BioReliance: study audits, validation audits, event reviews, client audits and supplier audits
·  Open-minded, flexibility and works with agility
·  Strong communication and interpersonal skills



Job Requisition ID: 211196

Location: Rockville

Career Level: C - Professional (1-3 years)

Working time model: full-time .buttontext1722e80f7dc3f6d2 a{ border: 1px solid transparent; } .buttontext1722e80f7dc3f6d2 a:focus{ border: 1px dashed #eb3c96 !important; outline: none !important; }

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.

Job Segment: Biotech, QA, Quality Assurance, Laboratory, Quality, Science, Technology