- Review related batch records associated with parenteral manufacture, semi-finished devices, and final packaged product.
- Performs final batch disposition of raw materials, components, active pharmaceutical ingredient (API), semi-finished and/or finished drug product and combination product batches, to ensure high quality medicine (GMP Compliance) is released within expected metrics to ensure timely release to market.
- Lead, mentor and coach site personnel on quality matters associated with the batch or batch disposition process.
- Provides guidance in operational areas to ensure robust Quality Systems and GMP compliance.
- Participate in self-led inspections and/or provide support during internal/external regulatory inspections.
- Effectively review/approve GMP documents to ensure quality attributes are met (i.e.: Non-conformances, procedures, protocols, specifications, and change controls).
- Participates in Six Sigma project or process improvement initiatives to improve productivity within the Batch Disposition work center and/or the site.
- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
- Bachelors or equivalent (Science or Engineering related degree preferred).
- At least 10 years working in the pharmaceutical or medical device industry in QA roles.
- Previous batch disposition experience supporting device, parenteral or drug substance products/materials.
- Proficiency with Manufacturing Execution Systems (PMX or similar), Inventory Management Systems (SAP or similar), Laboratory Information Management System (LIMS; such as, Darwin or similar), Deviation Management Systems (TrackWise).
- Demonstrated relevant experience in a GMP facility.
- Ability to make technical decisions, provide guidance to the site and lead others.
- Demonstrated strong oral and written communication skills.
- Demonstrated interpersonal skills and the ability to work as a team.
- Demonstrated attention to detail and ability to maintain quality systems.
- Previous regulatory inspection readiness and inspection execution experience.
- Ability to work overtime as required.
- CQA certification from the American Society for Quality (ASQ)
- Position is day shift and includes the requirement to work rotating weekends.
- Proven ability to work independently or as part of a Team to resolve an issue.
- Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations.
- The position is for the Lilly Research Triangle Park site and will allow for a flexible working environment with the ability to periodically work remotely based on site activities.
-
QA Batch Disposition
2 days ago
Eli Lilly and Company Durham, United States Full timeAt 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 th ...
-
Associate Director, Quality Assurance
5 days ago
Biogen Idec Durham, United StatesCompany DescriptionJob Description · About This Role · This critical position provides QA operational leadership for the RTP Drug Substance Manufacturing site in RTP, specifically in the areas of Small Scale Manufacturing (SSM), Flexible Volume Manufacturing (FVM), and Cell Banki ...
-
Associate Director, Quality Assurance
1 day ago
Biogen Durham, United StatesJob Description · About This Role · This critical position provides QA operational leadership for the RTP Drug Substance Manufacturing site in RTP, specifically in the areas of Small Scale Manufacturing (SSM), Flexible Volume Manufacturing (FVM), and Cell Banking. You will be res ...
-
Environmental Monitoring Associate
1 week ago
Piper Companies Durham, United StatesPiperCompanies is currently seeking aEnvironmental Monitoring Associate based inDurham, North Carolinafor work at a leading pharmaceutical company. This is a second shift/night time opportunityWednesday to Saturday 4pm to 2:30am Responsibilities of the Environmental Monitoring As ...
-
Pelthos - Quality Assurance Manager
2 weeks ago
Ligand Pharmaceuticals Durham, United StatesJob Description · Job Description · As a key member of the Quality Assurance team, the Pelthos Quality Assurance Manager is responsible for the implementation and maintenance of all aspects of the Pelthos Quality Management System in support of internal and outsourced GCP, GLP, ...
-
Environmental Monitoring Associate
6 days ago
Piper Companies Durham, United StatesPiperCompanies is currently seeking aEnvironmental Monitoring Associate based inDurham, North Carolinafor work at a leading pharmaceutical company. · This is a second shift/night time opportunityWednesday to Saturday 4pm to 2:30am · Responsibilities of the Environmental Monit ...
-
Microbiology Associate
5 days ago
Piper Companies Durham, NC, US, United StatesPiper Companies is currently seeking a Microbiology Associate based in Durham, North Carolina for work at a leading pharmaceutical company. · This is for the Tuesday – Saturday, 8:30-5PM shift, in-person and the Monday - Friday, 8:30-5PM shift. · Responsibilities of the Associat ...
-
QA Manager
2 weeks ago
FUJIFILM Holdings America Corporation Durham, United StatesOverviewThe QA Manager will be responsible for multiple and complex client programs within Quality Assurance. This role partners with internal and external stakeholders to ensure program management and overall product disposition activities, through management of programs and sys ...
-
QA Manager
2 weeks ago
FUJIFILM Corporation Durham, United StatesOverview: · The QA Manager will be responsible for multiple and complex client programs within Quality Assurance. This role partners with internal and external stakeholders to ensure program management and overall product disposition activities, through management of programs an ...
-
QA Manager
2 weeks ago
FUJIFILM Holdings America Corporation Durham, United StatesOverview · The QA Manager will be responsible for multiple and complex client programs within Quality Assurance. This role partners with internal and external stakeholders to ensure program management and overall product disposition activities, through management of programs and ...
-
QA Manager
3 weeks ago
FUJIFILM Corporation Durham, United StatesOverview: · The QA Manager will be responsible for multiple and complex client programs within Quality Assurance. This role partners with internal and external stakeholders to ensure program management and overall product disposition activities, through management of programs an ...
-
QA Manager
2 weeks ago
FUJIFILM Holdings America Corporation Durham, United StatesOverview · The QA Manager will be responsible for multiple and complex client programs within Quality Assurance. This role partners with internal and external stakeholders to ensure program management and overall product disposition activities, through management of programs and ...
-
Manager, Quality Assurance
1 week ago
Biogen Durham, United States Full timeJob Description · About this role · The Quality Assurance Manager is a fully onsite role responsible for strategic leadership of the Quality Factory Team for small and flexible volume manufacturing providing operational oversight of batch production activities and evaluation, a ...
-
Quality Associate
1 week ago
The Fountain Group Durham, United StatesThe Fountain Group is currently seeking a Quality Associate for a prominent client of ours. This position is located in RTP, NC. Details for the position are as follows: · Job Description: GMP DOCUMENT MANAGEMENT - NO TESTING ACTIVITIES · The Quality Assurance Associate is respo ...
-
Pelthos - Quality Assurance Manager
2 weeks ago
Ligand Pharmaceuticals Durham, United StatesJob Description · Job DescriptionAs a key member of the Quality Assurance team, the Pelthos Quality Assurance Manager is responsible for the implementation and maintenance of all aspects of the Pelthos Quality Management System in support of internal and outsourced GCP, GLP, and ...
-
Microbiology Associate
4 days ago
Piper Companies Durham, United StatesPiper · Companies · is currently seeking a · Microbiology Associate · based in · Durham, North Carolina · for work at a leading pharmaceutical company. · This is for the Tuesday – Saturday, 8:30-5PM shift, in-person and the Monday - Friday, 8:30-5PM shift. · Responsibilities of t ...
-
QA Manager
1 week ago
Fujifilm Corporation Durham, United StatesOverview · The QA Manager will be responsible for multiple and complex client programs within Quality Assurance. This role partners with internal and external stakeholders to ensure program management and overall product disposition activities, through management of programs an ...
-
Biogen Durham, United StatesJob Description · Remember to check your CV before applying Also, ensure you read through all the requirements related to this role. · About This Role: · This critical position provides operational oversight of the Manufacturing Technical Operations (MTO) function for the Smal ...
-
Sr. Coordinator II, Manufacturing
3 weeks ago
Biogen Durham, United States Full timeJob Description · Job Description · This site-based role supports our LSM manufacturing teams, primarily during core weekday business hours, but may require off-hours support. · The Sr. Coordinator II role provides leadership to manufacturing coordination and support activities ...
-
Specialist, Incoming Quality
1 week ago
Merck Durham, United States**Job Description** · Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across ...
QA Batch Disposition - Durham, United States - Lilly
Description
We're looking for people who are determined to make life better for people around the world.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Description:
Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and be a member of the Quality Assurance disposition team. The Quality Assurance Batch Disposition team assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities. The Quality Assurance Representative has oversight for the disposition of incoming materials, components, final disposition of semi-finished and/or finished drug combination products. As the authorized quality representative, serve as a technical leader within Quality to ensure proper adherence to Global and Local Quality requirements and ensure that there are adequate quality systems in place related to the Batch Disposition process to ensure product released to the market meets applicable GMP standards.
Responsibilities:
Basic Requirements:
Additional Skills/Preferences:
Additional Information:
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
QA Batch Disposition professionals in Durham
-
James DeCarlo
Permanent or contract Validation Engineer.