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Quality Assurance Validation Specialist

Your Role:  

The Quality Assurance Validation Specialist serves as the contact for quality projects and continuous improvement efforts regarding validation and quality risk management. The Quality Assurance Validation Specialist supports ongoing validation efforts and quality systems responsibilities in support of the manufacture, testing, and release of formulated drug substance. This role contributes to the development of concepts and techniques specific to validation and risk management. This role is paramount to ensure the efficacy and quality of our manufacturing processes which will ultimately yield safe drug products for patients.

 

Responsibilities:

  • Applies and enhances existing programs for the validation of new production and laboratory equipment and utilities, including major capital projects.
  • Drafts, reviews, executes and approves protocols and reports related to equipment and utilities validation. This includes deviation reporting during execution.
  • Ensures that the site Validation Master Plan remains current and aligned with corporate policies as it pertains to equipment and utility system validation.
  • Identifies and implements improvement opportunities for established Quality Systems, processes, procedures, and training to support corrective action, preventive action (CAPA), Change Control, Deviation, Risk Management, and Investigation processes.
  • Collaborates significantly with cross functional groups, including Quality, Manufacturing, Process Development, Facilities, and Regulatory Affairs.

 

Basic Qualifications

  • Bachelor's Degree in technical discipline (e.g. biotechnology, biology, engineering, chemistry)
  • Associate's Degree in technical discipline (e.g. biotechnology, biology, engineering, chemistry)
  • 3+ years experience in GMP environment

Preferred Qualifications

  • Knowledge of calibration methodology, equipment, and instruments.
  • Knowledge of software including: CAD, Minitab, and Microsoft Office
  • Experience with use of quality systems and processes in a regulated environment (GLP, cGMP, ISO)

RSREMD

Job Requisition ID:  187436
Location:  Madison
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.


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