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Quality Assurance Specialist

Company: Merck RPO
Location: Saint Louis
Posted on: November 22, 2021

Job 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


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.

Keywords: Merck RPO, St. Louis , Quality Assurance Specialist, Other , Saint Louis, Missouri

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