BioSpace, Inc.
Quality Assurance Representative - QA Product Complaints
BioSpace, Inc., Durham, North Carolina, United States, 27703
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.
The QA Product Complaints Representative serves as a power user and data steward for the Complaint Management TrackWise / Veeva system and performs complaint investigations for RTP manufacturing, assembly, and packaging for drug/device combination products and parenteral products.
The QA Product Complaints Representative is responsible for improving business processes and supporting customer service interactions to ensure key business objectives are met. The QA Product Complaints individual represents Quality Assurance on projects, including lean initiatives. Finally, the QA Product complaint individual is responsible for activities that include change controls, non-conformance investigations, procedure revisions, site impact analysis reviews, review and approval of cGMP documents, and maintaining regulatory compliance.
Key Objectives / Deliverables: Technical knowledge of complaint handling and/or quality systems Support the QA Compliance team and site in execution of the site readiness plan with focus on supporting transfer to new QMS system and provide oversight of the establishment of site data. Act as Data Steward for complaint data and ad hoc queries Maintain trend analysis for product and process performance Authors, periodic reviews, and acts as Subject Matter Expert for RTP site Product Complaint Management procedures. Review/Write/Approve GMP documents including technical reports, deviations, change controls as applicable. Perform complaint investigations for RTP manufacturing, assembly, and packaging for drug/device combination products and parenteral products. Support and initiate TrackWise/ Veeva Trend, RCI's, Tasks or other technical investigations, as applicable. Compile and document monthly metrics/quarterly metrics/ad-hoc reports. Collaborate and provide customer service for groups external to RTP, including, but not limited to Regional Centers, Global Patient Safety, CPQA, and IDM as needed. Compile and present complaint data for process teams, Site Quality Lead Team, and Process Flow team. Complete the APR complaints sections for each required product including compiling/summarizing data and presentation support as necessary. Participates in CAPA Review Board Meetings for Complaint Investigation CAPA Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Education Requirements:
Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience. At least 2 years working in the pharmaceutical or medical device industry in QA roles. Additional preferences:
Ability to compile data and metrics in reports understandable by management and business partners Attention to detail, self-management, problem solving; mentoring. Previous experience with complaint management systems including TrackWise / Veeva Proficiency with GMP computer systems including CAPA systems, and Document Control systems. Knowledge of regulatory requirements (e.g., cGMP, 21CFR820, ISO13485, Canadian MDR) Demonstrated strong oral and written communication skills Demonstrated strong technical writing skills. Other Information:
Ability to work 8-hour days - Monday through Friday is required on site; up to 4 days per month (e.g. 1 day per week) may be WFH applicable. May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operations. Ability to travel up to 5% to Indianapolis, IN for meetings and coordination with global regulatory organizations is required.
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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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
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.
The QA Product Complaints Representative serves as a power user and data steward for the Complaint Management TrackWise / Veeva system and performs complaint investigations for RTP manufacturing, assembly, and packaging for drug/device combination products and parenteral products.
The QA Product Complaints Representative is responsible for improving business processes and supporting customer service interactions to ensure key business objectives are met. The QA Product Complaints individual represents Quality Assurance on projects, including lean initiatives. Finally, the QA Product complaint individual is responsible for activities that include change controls, non-conformance investigations, procedure revisions, site impact analysis reviews, review and approval of cGMP documents, and maintaining regulatory compliance.
Key Objectives / Deliverables: Technical knowledge of complaint handling and/or quality systems Support the QA Compliance team and site in execution of the site readiness plan with focus on supporting transfer to new QMS system and provide oversight of the establishment of site data. Act as Data Steward for complaint data and ad hoc queries Maintain trend analysis for product and process performance Authors, periodic reviews, and acts as Subject Matter Expert for RTP site Product Complaint Management procedures. Review/Write/Approve GMP documents including technical reports, deviations, change controls as applicable. Perform complaint investigations for RTP manufacturing, assembly, and packaging for drug/device combination products and parenteral products. Support and initiate TrackWise/ Veeva Trend, RCI's, Tasks or other technical investigations, as applicable. Compile and document monthly metrics/quarterly metrics/ad-hoc reports. Collaborate and provide customer service for groups external to RTP, including, but not limited to Regional Centers, Global Patient Safety, CPQA, and IDM as needed. Compile and present complaint data for process teams, Site Quality Lead Team, and Process Flow team. Complete the APR complaints sections for each required product including compiling/summarizing data and presentation support as necessary. Participates in CAPA Review Board Meetings for Complaint Investigation CAPA Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Education Requirements:
Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience. At least 2 years working in the pharmaceutical or medical device industry in QA roles. Additional preferences:
Ability to compile data and metrics in reports understandable by management and business partners Attention to detail, self-management, problem solving; mentoring. Previous experience with complaint management systems including TrackWise / Veeva Proficiency with GMP computer systems including CAPA systems, and Document Control systems. Knowledge of regulatory requirements (e.g., cGMP, 21CFR820, ISO13485, Canadian MDR) Demonstrated strong oral and written communication skills Demonstrated strong technical writing skills. Other Information:
Ability to work 8-hour days - Monday through Friday is required on site; up to 4 days per month (e.g. 1 day per week) may be WFH applicable. May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operations. Ability to travel up to 5% to Indianapolis, IN for meetings and coordination with global regulatory organizations is required.
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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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