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Quality Assurance Specialist

Location: St. Louis, MO, USA

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Job Number: 7547

External Description:

This individual will work various internal departments to improve and execute processes in compliance with cGMP regulations in 21CFR 210, 211, Part 11 and in ICH Q7.

Duties in this role will include:

  • Write, review, and approve Investigations, OOS (out-of-specification), OOT (out-of-trend), complaints, CAPAs and Change Controls.
  • Participate in internal/external audits as needed.
  • Provide quality oversight and support for new product introductions as primary quality point of contact. Respond to quality-related customer questions.
  • Write, review, and approve Operating Procedures, Manufacturing documents, Technical Transfer Protocols, and other controlled documents under a Quality Managed System (QMS).
  • Review batch records for completeness and accuracy based on GMP requirements to ensure acceptable product and process consistency.
  • Interact with production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
  • Monitor for quality related issues and collaborate on resolution as quality on the floor.
  • Lead Process Improvement for Quality related initiatives/projects.

 

Who you are:

Minimum Requirements:

Bachelor’s Degree in Life Sciences, Chemistry, Pharmacy, Chemical Engineering, Process Engineering, or other life science related discipline AND 5+ years industry experience

OR

Master’s Degree in Life Sciences, Chemistry, Pharmacy, Chemical Engineering, Process Engineering, or other life science related discipline AND 2+ years industry experience

 

Preferred Qualifications:

  • Knowledge of ICHQ7 and API knowledge &/or experience
  • TrackWise and SAP experience
  • Proficiency in MS Word, MS Excel, MS PowerPoint and ability to learn and operate using other specific application software
  • Excellent communication (verbal & written) and customer interface skills
  • Excellent writing skills and experience writing technical documentation & reports
  • Ability to simultaneously manage multiple tasks/priorities  
  • Good problem-solving skills/abilities
  • Good time management and negotiating skills
  • Capacity for independent work required.
  • Data analysis, presentation, and experimental design knowledge

 

Additional Local need:

Environmental conditions will vary depending on specific job responsibilities; typically, 70-90% Office Environment, 10-30% Production, QC, Packaging.

Job Number: 232503

Community / Marketing Title: Quality Assurance Specialist

Location_formattedLocationLong: St. Louis, Missouri US

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