Quality Assurance Specialist, Batch Review - Indianapolis, Indiana, United States
13 hours ago
Job description
About Ossium
Ossium's mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood, immune, and orthopedic diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good.
About the Job
We're hiring a Quality Assurance Specialist to focus on Product Quality and uphold compliance with internal/external standards, regulations, policies, and procedures. This individual will review production and testing records related to the production of bone marrow and bone marrow derived products, ultimately signing off on the Quality Assurance (QA) release of the product for clinical applications. In this role, you will work closely with other departments to identify deficiencies, deviations, and improvement opportunities. Additionally, you'll be responsible for the execution and monitoring of various quality systems as well as assisting in the development and modification of internal systems to ensure that Ossium products maintain the highest standards of quality and safety.
This position reports to our Associate Supervisor, Product Quality.
Required Qualifications
- Associates degree in Life Sciences/Chemistry and 5+ years of experience in Quality
- Ability to complete tasks and projects with little oversight
- Capable of effectively assimilating information from visual inspection, written documents, and verbal inputs and identifying potential compliance risks
- High level of professionalism and good judgment
- Strong computer skills, including Microsoft Office
- Excellent written and oral communication skills
- Capability to operate with a high level of organization and excellent time management in a dynamic startup environment
- This position is based on site in our Indianapolis office; employees will report to Ossium's facility Monday through Thursday and have the option to work remotely on Fridays
- Qualified candidates must be legally authorized to be employed in the United States; Ossium is unable to provide sponsorship for employment visa status (eg, H-1B or TN status) for this position, either now or in the future
Preferred Qualifications
- Bachelor's Degree in Life Sciences/Chemistry
- Experience in tissue, organ or cell industry
- Understanding of 21 CFR 210, 21 CFR 211, 21 CFR 1271, AATB Standards, and other GMP requirements
- Familiarity with and previous experience working with Master Control, preferably in the Production Records module
Key Responsibilities
- Review technical production and testing records and identify deviations, non-conformances, and compliance issues
- Work across departments to resolve issues and implement improvements
- Coordinate and communicate effectively with impacted stakeholders
- Sign off on QA release of product for clinical applications
- Promote a culture of quality and continuous improvement through actions and education
- Track and trend data related to product quality
- Support audits as needed
In your first six months some projects you'll work on include:
- Review Production and Quality Control records and work with the departments to correct errors
- Perform the QA release of clinical product so that it can be used as a life-saving treatment
- Learn about Production and Quality Control activities to identify areas of improvement
Physical Requirements
This position involves work in a facility containing biological materials including human blood and tissues. Blood-borne pathogen training is required, and new hires will be given the option of Hepatitis B vaccination. Other physical demands or requirements include:
- Reporting to Ossium's facility during regular business hours
- Consistently adhering to Ossium's safety protocols, including wearing appropriate PPE
- Moderately noisy open-office environment
- Must be able to sit or stand for long periods of time
We offer a full slate of employee benefits including:
- Competitive salaries
- Stock options
- 401(k) matching
- Medical, dental and vision coverage
- Four weeks of PTO accrued (vacation & sick time) annually + 11 company holidays
- Employer paid life insurance and long term disability
- Gym membership/recreational sports reimbursements
If reasonable accommodation is needed, please contact our People Team at or Ossium Health complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities.
Principals / direct applicants only please. Recruiters, please do not contact this job poster.
Equal Opportunity Employer/Veterans/Disabled
Similar jobs
We're hiring a Quality Assurance Specialist to focus on Product Quality and uphold compliance with internal/external standards, regulations, policies, and procedures.This individual will review production and testing records related to the production of bone marrow and bone marro ...
2 weeks ago
InCOG Biopharma Services in Indianapolis is hiring a QA Batch Review & Disposition Manager who will work closely with the Senior Director of Quality. · This role offers the opportunity to work at INCOG's state-of-art sterile injectable CDMO during an exciting time of growth, · co ...
1 month ago
+This is an exciting opportunity to join the team as QA Batch Review leader . The role involves close collaboration with the Senior Director of Quality and will be instrumental in championing and developing the organization's batch review excellence. · +The ideal candidate will h ...
1 month ago
The QA Specialist – Batch Review will be instrumental in supporting major QA programs. They will also champion and develop the organization's Quality Mindset, and culture of efficiency, attention to detail, and on-time delivery. · Full lifecycle review and disposition of parenter ...
2 weeks ago
The Quality Assurance Specialist – Batch Review will provide support with identifying and closing Operational and Quality gaps. · Working closely with the QA Supervisor to champion and develop the organization's Quality Mindset. · Developing productive working relationships with ...
1 week ago
The Operations Batch Review Specialist is responsible for reviewing batch documentation post execution to ensure that all work completed was carried out in accordance with regulatory requirements, · Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs) whil ...
1 month ago
The Operations Batch Review Specialist is responsible for reviewing batch documentation post execution to ensure that all work completed was carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs) while ...
1 week ago
· Description · Operations Batch Review Specialist · The Operations Batch Review Specialist is responsible for reviewing batch documentation post execution to ensure that all work completed was carried out in accordance with regulatory requirements, Good Manufacturing Practices ...
2 days ago
· Description · Quality Assurance Manager - Batch Review and Disposition Summary · Working closely with the Senior Director of Quality, the Manager will be instrumental in championing and developing our new organization's batch review excellence and a culture of precision, scien ...
2 days ago
The Operations Batch Review Specialist is responsible for reviewing batch documentation post execution to ensure that all work completed was carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs) while ...
3 weeks ago
The Operations Batch Review Specialist is responsible for reviewing batch documentation post execution to ensure that all work completed was carried out in accordance with regulatory requirements. · Full batch documentation review of parenteral manufacturing Batch Records (Formul ...
3 weeks ago
The QA Operations Supervisor will provide direct supervision of QA Operations Specialists and ensure alignment with site quality objectives. · Coordinate daily activities, prioritize workload, and ensure timely completion of QA tasks across both functions. · Serve as the primary ...
1 month ago
Perform release of all manufactured materials including raw materials intermediates and drug products Confirm all documentation supporting these releases fully adhere to cGMP Ensure timely escalation to management of all applicable incidents Controlled issuance of batch records i ...
1 month ago
Summary · Help reimagine cancer care by shaping how our Radioligand Therapies (RLT) reach more patients—safely, reliably, and faster. At Novartis, we're pioneering the future of treatment through the fusion of nuclear medicine and precision oncology. · The QA Operations Superviso ...
2 days ago
+Help reimagine cancer care by shaping how our Radioligand Therapies (RLT) reach more patients—safely, reliably, and faster. · + · Bachelors' Degree preferably in Life Sciences chemistry or related relevant degree In lieu of degree 5 years in a role within pharma industry that in ...
1 month ago
Help reimagine cancer care by shaping how our Radioligand Therapies (RLT) reach more patients—safely, reliably, and faster. · ...
1 month ago
We're pioneering the future of treatment through the fusion of nuclear medicine and precision oncology.The QA Operations Supervisor provides hands on support for shop floor quality oversight and batch release activities while acting as supervisor to the QA Operations and Batch Re ...
1 month ago
Help reimagine cancer care by shaping how our Radioligand Therapies (RLT) reach more patients—safely, reliably, and faster. · ...
3 weeks ago
This is a high-impact leadership role at the center of our quality operations. As the Quality Manager, Batch & Donor Record Review, you'll lead the team responsible for donor eligibility and production batch record review within a 21 CFR 1271 and AATB-accredited environment, · en ...
2 weeks ago
This is a high-impact leadership role at the center of our quality operations. As the Quality Manager, Batch & Donor Record Review, you'll lead the team responsible for donor eligibility and production batch record review within a 21 CFR 1271 and AATB-accredited environment, · Le ...
2 weeks ago