Quality Engineer - Medasource : Job Details

Position: Quality Engineer / Quality Associate

Location: Lebanon, IN - Will also travel to vendor manufacturing sites as needed (10-20% of the time)

• TX, TN, Puerto Rico, Canada

Duration: 2-year rolling contract

Start: ASAP

The Quality Associate is an integral part of the manufacturing team and responsible for developing and inspection readiness, maintaining quality system procedures, ensuring GMP compliance and health authority.

Key Objectives/Deliverables:

• Review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for equipment, computer systems, logbooks, processes, and periodic product quality evaluations as appropriate to area of responsibility.
• Understand the Global Quality Standards and how they apply to manufacturing team -Monitoring and Maintenance of all aspects of GMP compliance
• Interpretation and application of emerging regulatory and GMP guidelines to the specific Quality Systems)/Program.
• Preparation and maintenance of site quality system policies and procedures.
• Monitoring of GMP compliance, GMP programs & systems by ensuring a regular presence in area of responsibility
• Communication and education of personnel in GMP requirements and regulations related to the areas) of responsibility.
• Review and approval of change controls, deviations, failure investigations, product quality complaints associated with the area(s) of responsibility
• Reports & escalates critical quality issues to the appropriate level of quality management for final resolution.
• Participate in quality risk management activities such as FMEA's.
• Audit & participation in the Site Self-Inspection program of the areas) of responsibility for compliance with Quality System policies, procedures, and guidelines.
• Maintenance of all aspects of GMP compliance for the area(s) of responsibility
• Assess the impact on product quality or equipment qualification of deviations associated with the area(s) of responsibility. Assure robust root cause analysis and effectiveness of corrective actions.
• Assurance that the Quality Systems)/Program remains in a validated state and within regulatory commitments.
• Develop knowledge about the manufacturing process of the products) manufactured at this site including but not limited to facilities, procedures, people expertise and quality systems.

Basic Requirements:

• Bachelor's degree (or equivalent) in scientific/engineering discipline.
• Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
• Working knowledge of Trackwise and/or Veeva Quality Documents systems
• Minimum 2 years of experience within pharmaceutical manufacturing in a QA role.

Additional Skills/Preferences

• Demonstrated knowledge and application ISPE C&Q and ASTM E2500 principles.
• Previous API facility or unit operations experience. (batch and continuous reactions, filtration, chromatography, centrifuge, dryer, utilities, air handlers, cleanrooms)
• Previous experience with MES (Syncade) and/or Kneat and/or ValGenesis
• ASQ Certified
• Computer System Quality Assurance experience

Additional Information:

• Ability to work 8-hour days - Monday through Friday. Ability to work off hours as required.
• During the project phase, this position will allow for a flexible working environment with the ability to periodically work remotely based on the scope and nature of the activities.
• Position is located in downtown Indianapolis until site north of Indy is available. Travel may be required (10-25%).