What are the responsibilities and job description for the Parenteral Quality Scientist position at Medasource?
Job Summary:
The QA Scientist plays a key role by offering daily oversight, support, and expert guidance to the site-based process teams in one of the following operational areas:
- Equipment Preparation and Formulation
- Parenteral Filling
- Visual Inspection
In this position, the QA representative advises on a wide range of topics including non-conformance investigations, change controls, procedure development, validation efforts, batch disposition, and commissioning and qualification activities. This role also provides mentorship and backup support for other QA Floor Support representatives. Maintaining GMP compliance and ensuring the site’s readiness for regulatory inspections are primary responsibilities.
Key Responsibilities:
- Promote and maintain a strong safety culture, leading initiatives to support corporate and site health, safety, and environmental objectives.
- Guide, mentor, and coach operations and support staff on quality-related topics.
- Maintain regular visibility in production areas to oversee GMP compliance and monitor quality system performance.
- Act as the designated Quality representative on the local process team, as defined by Lilly’s Manufacturing Standards for Operational Excellence.
- Evaluate and prioritize deviations occurring within the assigned process team.
- Collaborate with internal support teams and external partners to address and resolve product-related issues.
- Support self-inspection activities and assist during regulatory agency inspections.
- Initiate, review, and approve a variety of quality-related documents (e.g., deviations, procedures, technical reports, validation protocols, change controls, and engineering documentation).
- Contribute to continuous improvement initiatives aimed at enhancing productivity within both the process team and broader quality organization.
- Review and approve commissioning, qualification, and validation documentation for equipment and computerized systems to ensure compliance with applicable standards.
- Collaborate with other sites within the Global Parenteral Network to share best practices and drive improvements.
Basic Qualifications:
- Bachelor's degree in a scientific, engineering, or pharmaceutical discipline, or equivalent experience.
- At least 3 years of pharmaceutical industry experience, including direct batch disposition responsibilities.
- On-site work presence is required.
Preferred Qualifications and Skills:
- Strong understanding of current Good Manufacturing Practices (cGMPs).
- Prior experience in GMP-regulated production environments.
- Background in Commissioning, Qualification, and Validation (C&Q), including automation and computer systems validation.
- Familiarity with U.S., European, Japanese, and other global pharmaceutical regulatory requirements.
- Proficient in the use of relevant computer systems.
- Excellent verbal and written communication skills.
- Strong interpersonal skills with a proven ability to collaborate across teams.
- Skilled in root cause analysis and problem-solving.
- Exceptional attention to detail and a commitment to maintaining quality system integrity.
- Ability to work independently and within cross-functional teams to resolve issues.
- Strong technical writing skills.
- ASQ Certification is a plus.
- Experience in Computer System Quality Assurance (CSQA).
- Familiarity with Manufacturing Execution Systems (MES).
- Prior use of KNEAT or other electronic validation management software.
