Quality Assurance Specialist

Job Title: Quality Assurance

Location: Indianapolis IN 46285

Duration: 12+ Months

Duration:

The API EM Quality Assurance for Quality Control provides support to all QC activities at Contract Manufacturing organizations (CMs). The QA for QC position is essential for ensuring that all QC testing is in accordance with the validated methods and are compliant to cGMPs and regulatory commitments.

Basic Requirements:

• 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.
• Additional Preferences:
• 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.

Education Requirements:

• BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
• Other Information:
• Must complete required training for API EM Quality Assurance.
• No certifications required.
• 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.

Responsibilities:

Key Objectives/Deliverables:

• Serve as a liaison between CMs and client.
• Provide quality oversight of Quality control activities at CMs including being the initial point of contact for all quality-related issues with testing.
• Provide quality oversight of CM method validation or method transfer activities
• Escalate quality issues at CMs to Company QA management.
• Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
• Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
• Coordinate and perform quality responsibilities of API shipments for stability testing. Provide quality oversight of API EM stability program.
• Participate in regulatory inspection preparations with CMs.
• Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
• Provide quality support of Quality Control with the focus on holistic review of key activities associated with or impacting the quality control testing including deviations, change controls and countermeasures.
• Assess the impact of analytical deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
• Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
• Review and approve documents including, but not limited to, analytical procedures, change control proposals, deviations, analytical equipment qualifications, analytical methods and computerized system validations.
• Participate in APR activities.
• Participate in projects to improve productivity.
• Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.