Quality Assurance Manager

This range is provided by Kelly. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$75,000.00/yr - $90,000.00/yr

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Kelly Science & Clinical is seeking a Quality Assurance Manager for a direct hire opportunity with a leading specialty pharmaceutical company in Sacramento, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries.

Position Title: Quality Assurance Manager

Position Type: Direct hire

Overview:

As the Quality Assurance Manager for Parenteral products, you'll oversee QA activities in sterile injectable manufacturing, ensuring compliance with cGMP regulations and all pertinent standards. Your role involves leading a team for quality systems management, collaborating with production, QC, regulatory affairs, and engineering teams for product consistency and improvement.

Responsibilities

• Perform QA tasks in manufacturing areas and provide quality support.
• Triage quality issues, escalating as needed.
• Review and approve deviations, investigations, change controls, and batch records.
• Develop, review, and approve SOPs and QMS-related documentation.
• Participate in audits and support inspections, maintaining regulatory compliance.
• Train stakeholders on QMS and contribute to quality reviews.

Qualifications:

• Bachelor's degree (10+ years experience) or Master's degree (5+ years experience) in pharmaceuticals or biotechnology.
• Knowledge of cGMPs, Quality Systems, and FDA regulations.
• Strong communication, team collaboration, organizational skills, and critical thinking.
• Experience with electronic systems like SAP, LIMS, and Microsoft Office.

If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isn't the perfect match, your profile will remain within our network, ensuring you're connected to a wealth of future opportunities in the field of science and clinical research

• Seniority level
  
  Mid-Senior level

• Employment type
  
  Full-time

• Job function
  
  Quality Assurance and Management
• Industries Pharmaceutical Manufacturing

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