Job Description
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.
Requirements 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.
Other Information:
- 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
Job Tags
Permanent employment, Contract work