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Computer Systems Quality Assurance Advisor
1 month ago
At BioSpace, Inc., we are committed to delivering high-quality products and services to our customers. We are seeking a highly skilled Computer Systems Quality Assurance Advisor to join our team.
Key Responsibilities:
As a Computer Systems Quality Assurance Advisor, you will be responsible for ensuring that all computer systems used by our PRD team are compliant with current quality standards and regulatory requirements. This includes coordinating with our QA data integrity team to ensure that evolving data integrity expectations are implemented in a sustainable manner.
Additional Responsibilities:
Coach and mentor others in aspects of computer systems validation support, including System Development Lifecycle knowledge, problem solving, project management, and documentation design. Provide consultation and interpretation of local procedure, company and global standards and regulatory expectations. Review and approve applicable procedure to ensure compliance with company quality standards and regulatory requirements. Assess potential gaps between local procedure and company and global standards and facilitate remediation efforts. Influence and oversee the Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV) of GMP assets including review and approval of associated GMP deliverables. Evaluate potential product quality impact for any GMP-related incident (Change Control and non-conformance), perform initial leveling, and support the investigations to ensure proper RCA and establishment of effective CAPA to prevent reoccurrence. Perform Quality approvals for GMP documents such as Critical Alarm Audits, Utilities Reports, Business Reviews and Periodic Quality Evaluations. Ensure PR&D is audit ready at all times and participate in internal/external inspections.
Requirements:
Bachelor's degree in Science, Engineering, or related field. Previous experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.).
Preferred Skills:
Previous experience supporting cGMP API/drug substance manufacturing. Demonstrated strong oral and written communication skills. Demonstrated interpersonal skills and the ability to work as part of a team. Proven ability to envision and oversee implementation of continuous improvements. Previous QA experience. Proficient with data collection/analysis systems (e.g. Power Apps, Power Automate, SQL, Python, Tableau, PowerBI, etc.).
Additional Information:
This position supports on-site manufacturing activities in Indianapolis at the Lilly Technology Center North campus. Occasional travel may be required. Applicant may work in various areas/buildings within PR&D. Some allergens may be present. Mobility requirements and exposure to allergens should be considered when applying for this position. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups. #WeAreLilly
