Quality Assurance Manager

Kelly; Sacramento (CA); On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading specialty pharmaceutical company is seeking a Quality Assurance Manager in Sacramento to oversee QA activities for sterile injectables. This role involves ensuring compliance with cGMP regulations, leading quality systems management, and collaborating across departments. The ideal candidate should have a strong background in pharmaceuticals or biotechnology, equipped with a Bachelor's or Master's degree and extensive experience in quality assurance. The compensation is competitive ranging from $75,000 to $90,000 per year, reflecting the role's responsibilities and requirements.

Qualifications

• Bachelor's degree with 10+ years of experience or a Master's degree with 5+ years of experience.
• Knowledge of cGMPs, Quality Systems, and FDA regulations.
• Strong communication, teamwork, organizational skills, and critical thinking.

Responsibilities

• Oversee QA activities in sterile injectable manufacturing and ensure regulatory compliance.
• Lead a team for quality systems management and collaborate with various departments.
• Review and approve deviations, develop SOPs, and participate in audits.

Skills

Communication skills

Team collaboration

Organizational skills

Critical thinking

Education

Bachelor's degree in Pharmaceuticals or Biotechnology

Master's degree (5+ years experience)

Tools

SAP

LIMS

Microsoft Office

Job description

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

Base pay range

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

Direct message the job poster from Kelly

Senior Recruiter | PhD-level Scientist | Working Parent | Immigrant | Helping scientists answer the question of what's next?

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

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Management

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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