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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. QA Validations Audit team is responsible for QA review of new assay and equipment validations, to include pre- and post- execution documentation.

 

The responsibilities of this role will include, but are not limited to:  supporting Operations in implementing new assay methods and changes to existing assays, with a concentration on Product Characterization applications; review validation protocols, reports, and other validation deliverables for various types of equipment, assays, spreadsheets, and computerized systems; reviews SOPs/other documents for compliance requirements; reviews change control documentation for compliance requirements; assessment of Data Integrity requirements and compliance, as they apply to analytical systems and with documentation of cGMP methods; ensure the accuracy and completeness of full investigations of non-conformances within the Trackwise system; perform or review risk assessments for validated methods/equipment and formalized assessments under Failure Mode Effect Analysis (FMEA).

 

This position interacts with other departments on a daily basis, to ensure the integrity of new technologies brought to commercialization for BioReliance. The ability to actively collaborate and foster a cohesive working environment is a must. In addition, training and mentoring of newer team members would be required.  May require up to 20% travel.

 

 

Who You Are:

Minimum Qualifications:

 

  • Bachelor’s degree in life science field (biology, biotechnology, etc.) with 2+ years working experience in Quality Assurance

 

Preferred Qualifications:

 

  • Proficient working knowledge of standard validation practices (e.g. IOPQ, Installation Verifications, Validation Protocols, etc.)
  • Introductory to proficient working knowledge of Part 11, Annex 11, ICH Q2(R1) compliance.
  • Experience writing and reviewing governing documents, particularly in a validation and/or calibration environment
  • Capable of making quality related decisions and provide guidance in areas of expertise
  • Proficient knowledge of U.S. FDA regulations and European (EU) regulations (cGMP, GLP, Part 11, Annex 11, ICH Q2(R1), Data Integrity).
  • Advanced working knowledge of Good Documentation Practices
  • Strong oral and written communication and interpersonal skills

 

Job Requisition ID:  195742
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: Biotech, QA, Quality Assurance, Biology, Quality, Science, Technology

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