Fishers, Indiana, United States · On-site
$75k–$95k
Deviation Writer Summary INCOG BioPharma Services is seeking an experienced and detail-oriented Deviation Writer to join our team. This role is crucial for translating a variety of complex technical events into clear, ac…
Skills: Technical Writing, Root Cause Analysis, GMP Compliance, Deviation Management, Ishikawa Fishbone
Fishers, Indiana, United States · On-site
$27/hr–$25/hr
Inspection Associate Summary INCOG BioPharma Services is seeking a subject matter expert (SME) with capabilities in the inspection and of sterile drug products. The Inspection Associate is a key role within the organizat…
Skills: Sterile Drug Product Inspection, cGMP Compliance, Visual Inspection, Pharmaceutical Packaging, SOP Adherence
Fishers, Indiana, United States · On-site
INCOG BioPharma is seeking a highly motivated individual with subject matter expert (SME) capabilities in sterile pharmaceutical manufacturing process controls and industrial automation. The Equipment Specialist is a key…
Skills: Sterile Pharmaceutical Manufacturing, Industrial Automation, GMP Manufacturing, Aseptic Processing, Equipment Troubleshooting
Fishers, Indiana, United States · On-site
$60k–$75k
Shipping Specialist Summary We are seeking a highly organized and detail-oriented individual to join our team as a Shipping Specialist. The successful candidate will play a crucial role in ensuring the safe and efficient…
Skills: Pharmaceutical Shipping, cGMP, cGDP, ERP Systems, Material Management Systems
Fishers, Indiana, United States · On-site
$100k–$120k
The Manufacturing Supervisor is responsible for overseeing production operations, ensuring that all work completed is within appropriate timeframes, delivering daily expectations and assignments. Providing on floor suppo…
Skills: Production Oversight, cGMP Compliance, Aseptic Techniques, People Leadership, Batch Planning
Fishers, Indiana, United States · On-site
$75k–$90k
Weekend QC Scientist Summary The Weekend QC Scientist supports GMP manufacturing and laboratory operations by performing routine microbiology and chemistry testing, sample handling, and laboratory support activities unde…
Skills: Microbiology Testing, Chemistry Testing, GMP Compliance, Good Documentation Practices, Sample Handling
Fishers, Indiana, United States · On-site
$70k–$85k
Quality Control Chemist Summary: INCOG is seeking a Quality Control (QC) Chemist with a passion for working within a team, a desire to drive Quality processes in a regulated setting, and a commitment to upholding the int…
Skills: UHPLC/HPLC, GC, SoloVPE, UV-VIS, TOC
Fishers, Indiana, United States · On-site
$100k–$120k
The Manufacturing Supervisor is responsible for overseeing production operations, ensuring that all work completed is within appropriate timeframes, delivering daily expectations and assignments. Providing on floor suppo…
Skills: Production Oversight, cGMP Compliance, Aseptic Techniques, People Leadership, Batch Planning
Fishers, Indiana, United States · On-site
$21/hr–$28/hr
Job Summary The Quality Control Technician will be a member of the Quality Control Department. As a member of the team, he/she/they will be involved in routine QC sampling and testing of utilities, raw materials, in-proc…
Skills: QC Sampling, GMP, Analytical Chemistry, Sample Management, Equipment Calibration
Fishers, Indiana, United States · On-site
$21/hr–$28/hr
Job Summary The Quality Control Technician will be a member of the Quality Control Department. As a member of the team, he/she/they will be involved in routine QC sampling and testing of utilities, raw materials, in-proc…
Skills: QC Sampling, GMP, Analytical Chemistry, Sample Management, Equipment Calibration
Fishers, Indiana, United States · On-site
$80k–$95k
Procurement - Supplier Operations Specialist Summary We are looking for a motivated, self-starting individual to join INCOG’s evolving Supply Chain Team. Join us during the early stages of building dynamic, top-tier proc…
Skills: ERP Systems, Supplier Relationship Management, Procurement, Inventory Management, Supplier Onboarding
Fishers, Indiana, United States · On-site
$125k–$110k
Working closely with the QA Manager, the QA Batch Supervisor will be instrumental in supporting major QA programs. They will also be key in championing and developing the organization’s Quality Mindset, and culture of ef…
Skills: Batch Record Review, Aseptic Processing, Quality Management Systems, Root Cause Analysis, CAPA
Fishers, Indiana, United States · On-site
$125k–$145k
Manager of Device Assembly & Packaging Summary The Manager of Device Assembly & Packaging holds strategic and operational accountability for INCOG's device assembly and packaging (DAP) program, overseeing 24/7 DAP operat…
Skills: cGMP Compliance, Device Assembly, Packaging Validation, Lean Six Sigma, Regulatory Readiness
Fishers, Indiana, United States · On-site
$75k–$95k
Working closely with the QA Manager, the QA Senior Specialist will be instrumental in supporting major QA programs. They will also be key in championing and developing the organization’s Quality Mindset, and culture of e…
Skills: Batch Record Review, Aseptic Processing, GMP Compliance, Quality Management Systems, Root Cause Analysis
Fishers, Indiana, United States · On-site
$32/hr–$37/hr
The Manufacturing Specialist is a key technical role within INCOG BioPharma Operations. The ideal candidate must have experience in pharmaceuticals and/or biologics and GMP manufacturing. The Manufacturing Specialist wil…
Skills: GMP Manufacturing, Aseptic Processing, Fill and Finish, Equipment Troubleshooting, Cleanroom Operations
Fishers, Indiana, United States · On-site
$35/hr–$37/hr
Manufacturing Specialist – Filling Summary INCOG BioPharma is seeking a highly motivated individual with subject matter expert (SME) capabilities in sterile pharmaceutical manufacturing process controls and industrial au…
Skills: Sterile Pharmaceutical Manufacturing, Industrial Automation, GMP Manufacturing, Aseptic Processing, Equipment Troubleshooting
Fishers, Indiana, United States · On-site
$32/hr–$37/hr
The Manufacturing Specialist is a key technical role within INCOG BioPharma Operations. The ideal candidate must have experience in pharmaceuticals and/or biologics and GMP manufacturing. The Manufacturing Specialist wil…
Skills: GMP Manufacturing, Aseptic Processing, Fill and Finish, Cleanroom Operations, Equipment Troubleshooting
Fishers, Indiana, United States · On-site
$32/hr–$40/hr
Manufacturing Specialist – Filling Summary The Manufacturing Specialist’s primary responsibility is to efficiently and safely set up and operate various pieces of production equipment within the facility. They will be ex…
Skills: Aseptic Processing, GMP Compliance, Equipment Troubleshooting, Cleanroom Operations, Batch Record Documentation
Fishers, Indiana, United States · On-site
$140k–$150k
The Senior Quality Process Validation Specialist provides QA oversight of Process Design (Stage 1), Process Performance Qualification (Stage 2), and Continued Process Verification (Stage 3) activities across the site. Th…
Skills: Process Validation, QA Oversight, PPQ Studies, CPV Programs, Risk Assessment
Fishers, Indiana, United States · On-site
$22/hr–$29/hr
Position Summary The QC Sample Management Technician is a member of the Quality Control organization and is responsible for the end‑to‑end lifecycle management of QC samples in a GMP-regulated environment. This role ensu…
Skills: Sample Management, GMP Compliance, LIMS, ERP, Data Integrity
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The Deviation Writer is responsible for investigating and authoring technical reports on nonconforming events to identify root causes. They collaborate with cross-functional teams to implement effective corrective and preventative actions to prevent future occurrences.
Candidates must have a bachelor's degree in a scientific or engineering discipline and at least 3 years of technical writing experience in a regulated GMP environment. Proficiency in analysis tools and electronic document management systems is highly preferred.
INCOG BioPharma Services is seeking an experienced and detail-oriented Deviation Writer to join our team. This role is crucial for translating a variety of complex technical events into clear, accurate, and robust investigations. The Deviation Writer will work closely with the Manufacturing, Production Engineering, Manufacturing Sciences and Technology, Supply Chain, Quality, and other cross-functional teams to create comprehensive investigations that leverage facts and data to support robust root cause conclusions, effective corrective actions, and systematic all-encompassing preventative actions. The Deviation Writer will exemplify excellent interpersonal skills and be capable of developing productive customer-centric working relationships with internal and external customers and have a role with high visibility to all departments. The Deviation Writer will have strong familiarity with industry standard electronic Quality Management System(s) and Microsoft Office suite products.
They will thrive working autonomously utilizing strong self-management and organization skills but also be able to interact, collaborate, and lead within a team environment. The Deviation Writer will value the processes owned by internal customers and subject matter experts and will possess a demonstrated ability to support and influence positive outcomes in the application of that knowledge to wider processes.
· Understand, investigate, and author a variety of deviating conditions or nonconforming events across multiple technical departments, in alignment with Subject Matter Experts.
· Self-motivated to fact gather, analyze information, interpret data, utilize expertise from Subject Matter Experts, etc. in an effort to provide supportive evidence to the investigation and root cause.
· Experience utilizing a variety of analysis tools to support root cause identification; Ishikawa Fishbone, 5 Why, etc.
· Ability to critically think outside the box for robust corrective and preventative actions; leveraging automation and engineering controls to error-proof equipment and processes.
· Demonstrated ability to translate complex, technical processes and descriptions into simplified, understandable write ups.
· Eagerness to collaborate and partner with both internal and external stakeholders to comprehensively represent the facts of an investigation in a logical and presentable manner.
· Evaluating historical deviating conditions, adverse events, non-conformances, etc. in order to identify and prevent trends.
· Bachelor’s degree in a scientific, engineering, or technical discipline.
· Minimum of 3 years of experience in technical writing within a regulated GMP environment, preferably in the pharmaceutical, biopharmaceutical, or biotechnology industries.
· Proficient in writing clear, concise, and accurate technical documentation.
· Strong understanding of GMP manufacturing processes and regulatory requirements.
· Excellent organizational skills with high attention to detail.
· Ability to collaborate effectively with cross-functional teams and communicate complex information to diverse audiences.
· Familiarity with documentation tools and electronic document management systems (EDMS).
· Exceptional computer skills, particularly moderate to expert level experience with Microsoft Word and Microsoft Excel.
· Ability to manage multiple projects and deadlines simultaneously.
· Paid vacation days, amount based on tenure, and paid sick time
· 11 observed holidays
· 401(k) plan with company match up to 3.5% of salary, vested immediately
· Choice of health & wellness plans
· FSA and HSA programs
· Dental & vision care
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.
By submitting your resume and details, you are declaring that the information is correct and accurate.
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.
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
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
