API EM Quality Assurance Associate

Job Title: API EM Quality Assurance Associate
Location: Indianapolis, IN
Compensation: $50 - $57.10/hr
Type: Contract, Potential for extension or conversion to permanent

Responsibilities

• Serve as a liaison between Contract Managers (CMs) and company, providing clear communication and coordination.
• Provide quality oversight for Quality Control activities at CMs, including being the initial point of contact for all quality-related testing issues.
• Oversee CM method validation and transfer activities to ensure compliance and accuracy.
• Escalate quality issues at CMs to company QA management promptly and effectively.
• Assist in establishing and revising Quality Agreements with affiliates and customers to ensure clarity and compliance.
• Ensure adherence to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
• Coordinate and perform quality responsibilities related to API shipments for stability testing, including oversight of the API EM stability program.
• Participate in regulatory inspection preparations with CMs.
• Verify completion of documented checks such as Certificates of Testing and Certificates of Environmental Monitoring, and review deviations, changes, and batch documentation prior to batch release.
• Support Quality Control through holistic review of testing activities, deviations, change controls, and countermeasures.
• Assess analytical deviation investigations and changes, ensuring proper documentation and records.
• Maintain awareness of external regulatory findings impacting product quality and compliance.
• Review and approve key documents including analytical procedures, change controls, deviations, equipment qualifications, methods, and system validations.
• Participate in APPROVAL (APR) activities, process improvement projects, and Joint Process (JPT) and Post Launch Optimization (PLOT) teams.

• BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
• 5+ years of GMP Quality Control Laboratory knowledge and/or experience in API or finished product manufacturing, QA or Engineering.
  

• Testing experience with Small Molecule
• Thorough technical understanding of quality systems and regulatory requirements relating to quality control laboratories
• Knowledge of pharmaceutical manufacturing operations.
• Demonstrated coaching and mentoring skills.
• Experience in root cause analysis.
• Demonstrated application of statistical skills.
• Demonstrated strong written and verbal communications skills.
• Strong attention to detail.
• Proficiency with computer system applications.
• Excellent interpersonal skills and networking skills.
• Ability to organize and prioritize multiple tasks.
• Ability to influence diverse groups and manage relationships.
  

• Must complete required training for API EM Quality Assurance.
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
• Must be able to support 24 hour/day operations.
• Up to 20% travel US & OUS.
  
  

Ref: #558-Scientific