Fishers, Indiana, United States · On-site
$85k–$100k
The Process Specialist is responsible for working directly with the operations team and is to work closely with the quality systems team to provide information and/or feedback for manufacturing deviation investigations a…
Skills: Aseptic Manufacturing, CAPA Implementation, Root Cause Analysis, Deviation Investigation, Change Management
Indianapolis, Indiana, United States · On-site
$16/hr–$25/hr
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Columbus, Indiana, United States · On-site
$46/hr–$56/hr
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Columbus, Indiana, United States · On-site
$46/hr–$56/hr
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Merrillville, Indiana, United States · On-site
$10/hr–$20/hr
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New Castle, Indiana, United States · On-site
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Indianapolis, Indiana, United States · On-site
Division:Eskenazi Health Sub-Division: SEMHC Req ID: 26331 Schedule: Full Time Shift: Days Sandra Eskenazi Mental Health Center, Indiana's first community mental health center, provides comprehensive care for emotional a…
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Indianapolis, Indiana, United States · On-site
$28/hr–$32/hr
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Pendleton, Indiana, United States · On-site
$35/hr–$47/hr
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Marion, Indiana, United States · On-site
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Marion, Indiana, United States · On-site
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Jeffersonville, Indiana, United States · On-site
Our Company Adoration Health Overview Are you looking for a new marketing opportunity? Adoration Home Health is seeking a passionate, dedicated Home Health Account Executive to join our team in Jeffersonville, IN. Our Ho…
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Crown Point, Indiana, United States · On-site
Franciscan Health Crown Point 12750 S Francis Dr Crown Point, Indiana 46307 This is a general management position over the Surgical Pre-op and Post-op recovery with the bonus of knowing your work is ultimately improving …
Skills: Budget Management, Staffing, Performance Appraisals, Quality Compliance, Clinical Competence Oversight
Rockville, Indiana, United States · On-site
$25/hr–$33/hr
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Skills: Holistic Nursing Care, Patient Assessment, CPR, Behavioral Health Care, Medical Nursing
Plainfield, Indiana, United States · On-site
$36/hr–$48/hr
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Indianapolis, Indiana, United States · On-site
$61k–$74k/yr
At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise a…
Skills: CMMS Administration, Maintenance Scheduling, Contractor Oversight, GMP Compliance, EHS Standards
Indianapolis, Indiana, United States · On-site
$124k–$151k/yr
At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise a…
Skills: Commissioning, Qualification, Validation, GMP Compliance, Technical Writing
Indianapolis, Indiana, United States · On-site
$108k–$131k/yr
At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise a…
Skills: Commissioning Qualification and Validation (CQV), GMP Operations, Technical Writing, Risk Management, Deviation Investigation
Shelbyville, Indiana, United States · On-site
$16/hr–$25/hr
We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate…
Skills: Prescription Fulfillment, Customer Service, Inventory Management, Patient Care, Immunization Support
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The Process Specialist collaborates with operations and quality teams to investigate manufacturing deviations and implement CAPAs. They champion cross-functional process improvement projects to enhance efficiency and serve as a subject matter expert during regulatory audits.
Requires a minimum of 4 years of experience in a GMP environment with expertise in technical writing and batch record review. Candidates should possess strong analytical skills and familiarity with process control and regulatory requirements.
The Process Specialist is responsible for working directly with the operations team and is to work closely with the quality systems team to provide information and/or feedback for manufacturing deviation investigations and CAPA implementation.
Additionally, the Process Specialist will possess aseptic manufacturing knowledge to serve as subject matter expert and demonstrate ability to influence positive outcomes without direct reporting authority. The Process Specialist is expected to champion cross-functional process improvement projects that address process gaps and process efficiency while maintaining quality results.
The Process Specialist will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. Authoring comprehensive investigations that leverage facts and data to support robust root cause conclusions, effective corrective actions, and systematic all-encompassing preventative actions. They will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills.
Process Specialist – (I / Associate)
To work closely with MFG and QA systems to investigate deviations related to MFG activities. This specialist will be assigned straightforward CAPA related to SOP/WI revisions.
Process Specialist – (II / Base)
To work closely with MFG and QA systems to provide support for deviation investigation and CAPA implementation. This specialist is expected to champion cross-functional process improvement projects that address process gaps and process efficiency. Support client and regulatory audits for MFG department.
Process Specialist – (III / Senior)
To work closely with MFG and QA systems to serve as an SME during client or regulatory audits. This specialist is expected to champion major site/muti-departmental or client process improvement projects that address process gaps and process efficiency. Server as a management delegate for process update decisions and meetings.
· 1-2 years demonstrated working knowledge of aseptic manufacturing operations.
· 1-2 years in a people leadership role
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
By submitting your resume and details, you are declaring that the information is correct and accurate.
A CDMO with an unparalleled customer-centric approach.
Our services support injectable drug products, including technical transfer, analytical method development and validation, process scale up, and formulation & filling of vials, syringes and cartridges. In addition, we offer customized packaging services to include labeling, device assembly, auto injector assembly, cartoning, final packaging and integrated storage solutions at various temperature conditions.
Offices: Fishers , Indiana, US
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