Quality Line Operations Lead

2 days ago


Bloomington, United States Baxter Pharmaceutical Solutions LLC. Full time
Job Title: Quality Line Operations Lead

At Baxter Pharmaceutical Solutions LLC., we are seeking a highly skilled Quality Line Operations Lead to join our team. As a key member of our Quality Assurance Leadership Team, you will be responsible for ensuring the quality and compliance of our sterile injectable products.

Key Responsibilities:
  • Provide guidance and support to QALO direct reports to ensure compliance with regulatory agency regulations and guidelines.
  • Supervise QALO Sr. Technicians, Associates I, and Associates II to ensure quality oversight in manufacturing areas.
  • Lead cross-functional continuous improvement project teams utilizing Lean principles to improve quality and efficiency.
  • Develop and maintain documentation procedures, QA instructions, and department policy procedures to ensure product compliance regulations are followed.
  • Represent QALO during client audits and regulatory inspections to establish credibility and demonstrate compliance with cGMPs.
Requirements:
  • BS degree in a science discipline and 2 years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or Associate's degree with at least 3 years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or no degree with at least 5 years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience.
  • 2+ years experience in a supervisory/leadership role.
  • Working knowledge of FDA CFR 210,211 and other applicable regulations, and Good Documentation Practices (GDP).
  • Knowledge of aseptic manufacturing processes preferred.
  • Attention to detail and ability to stay organized.
  • Intermediate (or higher) proficiency in Microsoft Office Suite (Word, Excel, and Outlook).
What We Offer:
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and collaborative work environment.
  • Recognition and rewards for outstanding performance.

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking for a new challenge, please submit your application.


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