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API EM Quality Assurance Associate

System One • Indianapolis, IN • 7h ago

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

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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