BioSpace, Inc.
QA Materials Management & Data Stewardship
BioSpace, Inc., Indianapolis, Indiana, us, 46262
Job Details
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Description:
To provide support to the Parenteral Products materials management systems. The Parenteral Materials Management team provides Quality Oversight for the suppliers and materials utilized by the Parenteral Site. This position supports all Materials Management activities relative to the Parenteral Products Site in order to ensure appropriate Quality Oversight.
Key Objectives / Deliverables:Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.Coordinates the appropriate tasks to maintain the Approved Supplier List including additions, deletions and modifications to existing materials and suppliers.Conduct material and supplier risk assessments and periodic reviews of supplier performance.Coordinate and write Supplier, Service Provider, and Affiliate Quality Agreements, including networking with site resources to ensure compliance to associated requirements.Provide input, guidance and recommendation for Supplier / Service Provider approval and certification activities.Maintain complaint database (track supplier responses for warehouse, incoming and operations complaints).Provide input and guidance to site activities (e.g., six sigma, new product / process development, change controls) as material quality SME.Be able to perform materials LMS data steward functions, if necessary.Review and Redline GMP documents, including specifications and procedures. Provide procedure ownership and subject matter expertise, as necessary.Provide the voice of quality to the Parenteral Supplier Committee, providing input and support as needed in order to ensure compliance.Support regulatory inspection activities as needed by providing documentation and SME support.Track and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee.Work with global resources, as necessary, to achieve compliance with requirements.Lead, as required, local or global teams, committees, or other groups to resolve quality issues and ensure site compliance to Lilly Standards and external regulations.Minimum Requirements:
Demonstrated relevant experience in a GMP facilityProficiency with current computer systems and applications including Microsoft Office products, LMS, EDMS and TrackWise or similar systemsStrong oral and written communication and interpersonal skillsAbility to influence externally with suppliers and resources across sitesResponsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site GoalsAdditional Preferences:
Experience with Lilly deviation and change control processesExperience in material management, quality systems and cGMPsEducation Requirements:
Bachelors' Degree or equivalent experience in a science - related fieldOther Information:
Overtime may be required.May be required to respond to operational issues outside of core business hours and days.Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant.Mobility requirements and exposure to allergens should be considered when applying for this position.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Description:
To provide support to the Parenteral Products materials management systems. The Parenteral Materials Management team provides Quality Oversight for the suppliers and materials utilized by the Parenteral Site. This position supports all Materials Management activities relative to the Parenteral Products Site in order to ensure appropriate Quality Oversight.
Key Objectives / Deliverables:Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.Coordinates the appropriate tasks to maintain the Approved Supplier List including additions, deletions and modifications to existing materials and suppliers.Conduct material and supplier risk assessments and periodic reviews of supplier performance.Coordinate and write Supplier, Service Provider, and Affiliate Quality Agreements, including networking with site resources to ensure compliance to associated requirements.Provide input, guidance and recommendation for Supplier / Service Provider approval and certification activities.Maintain complaint database (track supplier responses for warehouse, incoming and operations complaints).Provide input and guidance to site activities (e.g., six sigma, new product / process development, change controls) as material quality SME.Be able to perform materials LMS data steward functions, if necessary.Review and Redline GMP documents, including specifications and procedures. Provide procedure ownership and subject matter expertise, as necessary.Provide the voice of quality to the Parenteral Supplier Committee, providing input and support as needed in order to ensure compliance.Support regulatory inspection activities as needed by providing documentation and SME support.Track and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee.Work with global resources, as necessary, to achieve compliance with requirements.Lead, as required, local or global teams, committees, or other groups to resolve quality issues and ensure site compliance to Lilly Standards and external regulations.Minimum Requirements:
Demonstrated relevant experience in a GMP facilityProficiency with current computer systems and applications including Microsoft Office products, LMS, EDMS and TrackWise or similar systemsStrong oral and written communication and interpersonal skillsAbility to influence externally with suppliers and resources across sitesResponsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site GoalsAdditional Preferences:
Experience with Lilly deviation and change control processesExperience in material management, quality systems and cGMPsEducation Requirements:
Bachelors' Degree or equivalent experience in a science - related fieldOther Information:
Overtime may be required.May be required to respond to operational issues outside of core business hours and days.Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant.Mobility requirements and exposure to allergens should be considered when applying for this position.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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