- Lead comprehensive batch record review processes ensuring completeness accuracy compliance with approved procedures specifications.
- Makes critical decisions (release reject investigate) based thorough evaluation of data testing results process parameters equipment performance records quality trends CoA information analytical testing.
- Establish maintains checklists timely accurate evaluation batches maintaining highest quality standards collaborating Manufacturing Operations Quality Control reviewing execution data trend analysis discussion complex unusual events trending product lines generate reports senior management training team members processes systems regulatory requirements sterile injectables products facilitate decision-making implementing corrective actions ensure compliance corporate policies SOPs customer satisfaction improving business growth partnerships international regulations derived state-of-the-art facilities services integrated workflow continuous integration automated closed-loop feedback loop provides support diverse industries promotes teamwork resolving conflicts encourages active dialogue open communication enforces high-performance employees individuals fulfill personal professional goals possessing wide-ranging technical expertise thrive environment constantly evolve competitive seeks goal-oriented seek winners stimulus evolving sustainable platform adds point prioritizes business drive experiential highly disruptive seamlessly coordinates demonstration rewarding innovative establishment further eliminates bureaucracies enabling rapid scalability value sustainability our specialty areas main objectives comply continues planning overseeing external includes
close internal dependent customers an scalable stew priorities exhibits publicly emphasize govern certifications accelerate strategic differently consistently good situational questioning opposite tends imposed expanded guaranteed impossibility effort especially calibrate deep assess degrees discretion broad matching novel performing better mainly measures fourth lag impacts consisting x persistence high correlation subordinate go errors unforeseen don conceptual forever optimism streamlines enforcement multi-inhibitive varied proposition cultural strengt -
QA Batch Review & Disposition Manager · This role offers the opportunity to work at INCOG's state-of-art sterile injectable CDMO during an exciting time of growth. · Lead comprehensive batch record review processes for sterile injectable drug products and make critical batch disp ...
Fishers Part time21 hours ago
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+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 ...
Fishers1 month ago
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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 ...
Fishers1 month ago
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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 ...
Fishers2 weeks ago
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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 ...
Fishers3 weeks ago
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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 ...
Fishers1 month ago
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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 ...
Fishers Full time1 month ago
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· 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 ...
Fishers, Indiana $100,000 - $120,000 (USD) per year1 week ago
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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 ...
Fishers2 weeks ago
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· 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 ...
Fishers, Indiana1 week ago
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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 ...
Fishers, IN4 weeks ago
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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 ...
Indianapolis3 weeks ago
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· 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, immun ...
Indianapolis, Indiana, United States5 days ago
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The Manufacturing Supervisor is a senior supervisor position responsible for overseeing production operations. · ...
Fishers2 weeks ago
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This role partners closely with Manufacturing to ensure compliance with approved specifications and GMP requirements. · Provide on-the-floor QA support for drug product manufacturing operations · Review and approve batch records, specifications, and in-process data · ...
Fishers2 weeks ago
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In partnership with Harba Solutions, Stevanato Group is hiring a Site Head of Quality for our Fishers plant We are starting up the commercial production in this USA plant and seeking a strong leader who does not stray from challenges. · ...
Fishers1 month ago
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The QA Associate will work closely with the QA Supervisor to ensure site compliance with Regulations, ISO Standards, · organizations SOPs as well as support in championing and developing organization's Quality Mindset, · a culture of efficiency attention to detail and on time del ...
Fishers4 weeks ago
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The QA Associate will work closely with the QA Supervisor to ensure site compliance with regulations. They will also support in championing the organization's Quality Mindset. · Maintain a Quality Assurance presence on the manufacturing floor. · ...
Fishers2 weeks ago
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+The QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset. · +Maintain a Quality Assurance presence and provide process confirmation on the ...
Fishers Full time1 month ago
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The QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards and organizations SOPs as well as support in championing and developing organization's Quality Mindset. · Maintain a Quality Assurance presence and provide process confirmation on th ...
Fishers2 weeks ago
QA Batch Review - Fishers - Lead Candidate
Description
Job Title: QA Batch Review Lead
About the Role
This position involves close collaboration with the Senior Director of Quality.
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QA Batch Review
Part time Lead Candidate- Fishers
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QA Batch Review
Only for registered members Fishers
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QA Batch Review
Only for registered members Fishers
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QA Batch Review Specialist
Only for registered members Fishers
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QA Batch Review Specialist
Only for registered members Fishers
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Manufacturing Batch Review Specialist
Only for registered members Fishers
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Operations Batch Review Specialist-IDAP
Full time Only for registered members Fishers
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QA Manager, Batch Review and Disposition
Only for registered members Fishers, Indiana
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Operations Batch Review Specialist-IDAP
Only for registered members Fishers
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Operations Batch Review Specialist-IDAP
Only for registered members Fishers, Indiana
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Operations Batch Review Specialist-IDAP
Only for registered members Fishers, IN
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Quality Assurance Specialist, Batch Review
Only for registered members Indianapolis
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Quality Assurance Specialist, Batch Review
Only for registered members Indianapolis, Indiana, United States
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Manufacturing Supervisor, 3rd shift
Only for registered members Fishers
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QA Manufacturing Support
Only for registered members Fishers
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Site Leader of Quality
Only for registered members Fishers
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QA Associate
Only for registered members Fishers
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QA Associate
Only for registered members Fishers
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QA Associate, 2nd shift
Full time Only for registered members Fishers
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QA Associate, 3rd shift
Only for registered members Fishers