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Quality Assurance Specialist

The Quality Assurance Department at this site supports quality functions for Active Pharmaceutical Ingredients (APIs) under Good Manufacturing Practice guidelines (ICHQ7).

  

Your role:

  • You will work within various internal departments to improve and execute processes used in an ICHQ7 environment 
  • Review Root Cause Analysis investigations and ensure adequate CAPAs are put in place to reduce or eliminate recurrence of issues. 
  • Documentation Control: write, review, and approve Operating Procedures, Specifications, Master Manufacturing Procedures, and other QA controlled documents
  • Ensure that all aspects of product release meet analytical, production, packaging, and labeling specifications in accordance with established quality systems
  • Provide extensive review of manufacturing and quality control batch records, including verifications of calculations, approval of MMFs, MPFs, generation of Certificates of Analysis, and other release documents.
  • Interact with the production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
  • Respond to quality-related customer questions.

 

Who you are:

 

Basic Qualifications:

  • B.S./B.A. in Life Sciences, Chemistry, Pharmacy, Chemical or Process Engineering
  • 1+  Year of experience with ICH Q7

 

 

Preferred Qualifications:

  • Current API knowledge and/or experience desired.
  • Good computer skills, including proficiency in MS Word, MS Excel, MS Powerpoint, and the ability to learn and operate other specific application software, required
  • Excellent written and verbal communication and customer interface skills required
  • Excellent writing skills and experience writing technical documentation and reports required
  • Ability to simultaneously manage multiple tasks/priorities required
  • Good problem-solving skills/abilities required
  • Good time management and negotiating skills required
  • Capacity to work independently required

 

RSRMS 

Job Requisition ID:  204841
Location:  St. Louis
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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