Deviation Writer
Writer job in Indianapolis, IN
Process Alliance is a leading engineering consultancy firm dedicated to delivering innovative solutions in engineering, automation, manufacturing services, and medical devices. With a commitment to being a better model of problem solving, we have been at the forefront of providing cutting-edge engineering services to clients across the life science industry. Our team of experts thrives on solving complex challenges and driving technological advancements to meet the evolving needs of our clients.
Overview:
We're hiring a deviation writer to join a pharmaceutical manufacturing team in Indianapolis, Indiana. This full-time, on-site role is ideal for an early-career scientist or engineer with 1-2 years of experience in GMP manufacturing or quality support.
Key Responsibilities:
Write detailed deviation reports, documenting investigations in compliance with GMP standards
Collaborate with cross-functional teams (QA, manufacturing, QC, engineering) to gather data and support root cause analysis
Ensure timely closure of deviations and support CAPA documentation as needed
Participate in deviation trending and reporting to drive continuous improvement
Qualifications:
Bachelor's degree in a scientific or engineering or related field
1-2 years of experience in the pharmaceutical industry
Experience writing or supporting GMP deviation investigations preferred
Packaging experience is a plus
Quality Control Lab experience is a plus but not required
Strong analytical and writing skills
Familiarity with quality systems is a plus
About Our Culture:
At Process Alliance, we strive to be a better model for how problems are solved, and solutions are delivered. We believe in providing a supportive and inclusive work environment where employees can thrive both personally and professionally. Join our team and be part of a company that is shaping the future of engineering solutions.
Learn more about us:
Visit our website at *********************** to explore our projects, expertise, and the impact we make in the engineering and consultancy space.
Process Alliance is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences.
Technical Writer
Writer job in Indianapolis, IN
Job Title: Technical Writer / Analyst
Contract Duration: 3-months (intention of a long-term engagement)
We are seeking a mid-level Technical Writer / Analyst to support a major Warehouse Execution System (WES) implementation and other site-wide IT initiatives at a leading pharmaceutical distribution site. This role is ideal for someone who is detail-oriented, proactive, and eager to roll up their sleeves to drive documentation and validation efforts across multiple projects and stakeholders.
Key Responsibilities:
Draft and manage documentation (e.g., requirement specs, test plans, evaluation reports) across multiple concurrent IT and (EWM systems) projects.
Collaborate with Subject Matter Experts (SMEs), Project Managers, and Quality teams to gather technical input and translate it into clear, compliant documentation.
Support test planning and execution in the first month, followed by ongoing design and documentation of validation deliverables.
Assist in wrangling SMEs and coordinating across global and local teams to ensure timely delivery of documentation.
Contribute to evaluation plans and reporting for system-wide initiatives, including miscellaneous reports and site-wide planning deliverables.
Ensure adherence to System Development Life Cycle (SDLC) and regulatory requirements (GXP, data integrity, privacy).
Participate in technical discussions to stay aligned with evolving project needs.
Interface with corporate and global teams, initially supporting local execution and potentially broader compliance initiatives.
Ideal Candidate Profile:
3-5 years of experience in technical writing, or IT documentation-preferably in a regulated environment.
Strong understanding of GXP, SDLC, and data integrity principles.
Comfortable working in fast-paced, agile environments where documentation is often being created from scratch.
Excellent written and verbal communication skills; able to synthesize complex technical input into clear, structured documents.
Demonstrated ability to take initiative, chase down information, and work independently while coordinating with multiple stakeholders.
Background in Warehouse Management or IT (Computer Science, Information Systems, or related field) is preferred.
Experience with WES platforms or warehouse systems is a plus.
Additional Notes:
This role is onsite and will require close collaboration with both contractors and internal teams.
The successful candidate will be part of a growing team and may move with the group as projects evolve.
There is a strong emphasis on extension-this is a great opportunity for someone looking to grow into a long-term role.
Brooksource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.
Social Content Creator (Freelancer) - IN
Writer job in Indianapolis, IN
About the Role:
We are seeking a creative and highly motivated Content Creator to join WITHIN's Creative Production team in a full-time capacity. If you live and breathe social media, especially platforms like TikTok, and have a knack for creating thumb-stopping, authentic content, this role is for you! You'll be instrumental in bringing our brand(s) to life online, transforming ideas and trends into engaging content, with a strong focus on User-Generated Content (UGC) styles. Reporting to the Post Production Supervisor, you will be a key player in our content creation engine, collaborating across teams to produce timely and relevant social-first content.
Responsibilities include but are not limited to:
Trendspotting & Ideation: Constantly monitor social media platforms (especially TikTok, Instagram Reels, etc.) to identify emerging trends, sounds, and formats, translating them into actionable content ideas for our accounts.
Content Creation: Conceptualize, script, shoot, and edit engaging short-form video and static content optimized for various social media platforms, capturing an authentic, often UGC-style, look and feel.
UGC Focus: Develop and execute strategies to encourage and leverage user-generated content, as well as create brand content that mimics authentic UGC.
Creative Collaboration: Work closely with the [Social Media Manager / Content Lead] and broader Marketing/Creative teams to align content with campaign goals, brand voice, and platform best practices.
Basic Editing & Graphics: Perform necessary edits, add text overlays, incorporate trending audio, and utilize basic motion graphics or in-app effects to enhance content and ensure it's platform-native.
Asset Management: Organize and manage digital assets (raw footage, edited videos, graphics) for social media use, ensuring easy access and archiving.
Platform Management: Stay updated on best practices, features, and algorithm changes across key social media platforms.
Performance Awareness: Have a general understanding of what resonates with audiences and contribute insights based on content performance.
Requirements:
Social Media Native: Proven experience creating engaging content specifically for platforms like TikTok, Instagram Reels, YouTube Shorts. You understand the nuances, trends, and culture of these spaces intrinsically ("chronically online" is a plus!).
Content Creation Skills: Demonstrated ability to shoot (often with a smartphone) and edit compelling short-form video content.
Editing Proficiency: Comfortable using mobile editing apps (e.g., CapCut, InShot) and/or basic desktop software (e.g., Adobe Premiere Rush, iMovie, basic Premiere Pro).
UGC Acumen: Strong understanding of what makes UGC effective and experience creating content in that authentic style.
Creative & Agile: Ability to generate creative ideas quickly and adapt to the fast-paced nature of social media trends.
Collaborative Spirit: Excellent communication skills and ability to work effectively within a team environment.
Organizational Skills: Ability to manage multiple projects simultaneously and meet deadlines.
Our interview process includes, but is not limited to the following:
Excel and Typing Test
We offer a competitive hourly wage based on ability level:
Hourly Rate DOE
This is a remote role.
About WITHIN & Brkfst.io
WITHIN is the world's first Performance Branding company, partnering with some of the biggest brands in the world to drive business growth through innovative marketing strategies. Our integrated operating model collapses the traditional marketing silos between creative and media, performance and brand, and across media channels. With a full suite of offerings including media, creative, SEO, Lifecycle, Retail Media, Affiliate and Influencer, we're able to work with our brand partners in an integrated fashion, allowing us to align marketing strategies back to core business objectives. Client teams at WITHIN are trained on how to always act as a trusted business partner, acting as a fiduciary to client needs above our own.
Teams at WITHIN have the ability to work with iconic brands such as The North Face, Timberland, Ben and Jerry's and Jose Cuervo. Everyone at WITHIN wants to grow and be challenged. It's a collaborative place made up of small, closely knit and versatile teams that are fast and adaptive to solve problems and build systems.
Check out some of our work!
Brkfst.io is an incubated venture within WITHIN, focused on connecting creators with major brands to produce impactful ads at scale.
We are, and we connect creators with big brands to make impactful ads at scale. We have a network of thousands of content creators with a variety of different skill-sets, and we're looking to build a program that empowers them to create great ads for brands like Corkcicle, Perfume.com, Casper Mattresses, & more!
This is a very ambitious project and our roadmap is full of exciting features, so we're looking for people who love innovation and want to be challenged. We're a small team of scrappy individuals who are growing fast, and we're looking for someone to grow with us.
We weave AI into everything we do, using the latest tech across all teams to innovate, work smarter, and make better decisions. Whether it's in creative, operations, or anything else, AI helps us level up and do things at a whole new scale. We expect our people to use AI in their daily work, fully embracing it as a critical tool to help us succeed.
Join Our Network!
Stay connected with us and be the first to know about new opportunities, industry insights, and updates.
Follow us on:
LinkedIn
WhatsApp Community
Instagram
Tik Tok
Locations
New York City: 43-01 22nd St, Suite 602, Queens, NY 11101, United States
Bogotá: WeWork Av. Carrera 19 #100-45 Usaquén, Piso (Floor) 10, Bogotá, Distrito Capital de Bogotá 110111, Colombia
Mexico City: Av. Paseo de la Reforma 296, Piso (Floor) 25, Oficina 111, Ciudad de México, CDMX 06500, México
Auto-ApplyHSE Permit Writer
Writer job in Lebanon, IN
At 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 the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At 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 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Organization Overview:**
Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.
**Position Brand Description:**
The Health Safety and Environment (HSE) Permit Writer will develop and maintain safe work permits within the production building. A successful candidate will interface with the Process Team and Project Team to manage equipment availability.
In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.
**Responsibilities:**
+ Safe work permit preparation including the coordination of operations, project, and maintenance personnel.
+ Execute the required safe work permits, which includes but is not limited to lock out tag out (LOTO), hot work, confined space entry, etc.
+ Develop and maintain equipment specific instructions including but not limited to lock-out, tag-out.
+ Develop and maintain confined space entry risk assessments.
+ Develop and maintain permitting equipment and supplies.
+ Perform safety audits and maintain an audit ready status.
+ Review and monitor relevant Standard Operating Procedures (SOPs) and SOP updates. Execute unplanned SOP changes.
+ Influence adherence to project and maintenance schedules.
+ Support Process Engineers/Maintenance/Projects and Supervision in daily operations.
+ Identify and support the implementation of improvements from Operations.
+ Ownership of daily tasks, preventative maintenance or breakdowns.
+ Conduct continuous improvement projects which are aligned with safety and quality expectations and meet operational needs
+ Understand Health, Safety & Environmental-regulated environment and application of Health & Safety/Process Safety standards.
+ Understand other area processes & their operational hazards and being able to react appropriately.
+ Actively participate in assigned building & area operations such as safety audits, procedure coordination, housekeeping and improvement projects.
+ Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.
**Basic Requirements:**
+ High School Diploma or equivalent
+ Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
+ Completion of Post Offer Exam or Completion of Work Simulation if applicable.
+ Ability to effectively communicate (electronically, written and verbal).
+ Basic computer skills (desktop software) are required.
**Additional Preferences:**
+ Previous experience in facility/area start-up environments.
+ Previous experience in a pharmaceutical manufacturing operation with PSM-regulated/hazardous chemicals.
+ Solid understanding of FDA guidelines and cGMP requirements.
+ Strong organizational skills and ability to handle and prioritize multiple requests.
+ Knowledge of lean manufacturing principles.
+ Flexibility - ability to troubleshoot and triage challenges.
+ Ability to understand technical nomenclature and language as well as work with mathematical formulas.
+ Manual material handling as appropriate.
+ Bend, reach, stretch, climb ladders, and work in tight spaces.
+ Stand for long period.
**Additional Information:**
The Safety Permit Writer role operates on a work schedule of Monday through Friday, 8 hours per day. The job may also involve some non-scheduled call-in time to respond to plant emergencies etc. and some scheduled call-in time to attend training activities etc.
+ Ability to work flexible schedules during startup period.
+ Ability to work overtime as required.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_************************** ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$28.84 - $42.31
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
Deviation Writer
Writer job in Fishers, IN
INCOG BioPharma Services is seeking an experienced and detail-oriented Deviation Writer to join our Manufacturing Engineering 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.
Essential Job Functions:
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.
Special Job Requirements:
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.
Additional Preferences:
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.
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.
By submitting your resume and details, you are declaring that the information is correct and accurate.
Auto-ApplyINCOG BioPharma Services Careers - Supply Chain Specification Writer
Writer job in Fishers, IN
INCOG BioPharma Services is seeking an experienced and detail-oriented Specification Writer to join our supply chain team. This role is crucial for translating complex technical data into clear, accurate, and accessible documentation. The Specification Writer will work closely with supply chain, external vendors, clients and other cross-functional teams to create comprehensive documentation that supports new material specifications and updates for existing specifications, ensuring that all materials meet regulatory and quality standards.
Essential Job Functions:
* Develop, author, and maintain material specifications, ensuring that the information is clear, detailed, and usable by both technical and non-technical stakeholders.
* Ensure all documentation is compliant with GMP standards and meets regulatory requirements
* Work closely with Supply Chain, vendors, Quality, project teams, and clients to gather necessary technical information, facilitate effective communication, and ensure that all documentation reflects the latest material information and stakeholder feedback.
* Understand material requirements, track progress of specifications, and support prioritization to ensure operational readiness.
* Support escalation, documentation, and generate action items for path forward when specification approval does not align with operational timelines or requirements.
* Establish and maintain documentation standards to ensure consistency across all technical documents. Continuously review and update documents to reflect process improvements, new requirements, and regulatory changes.
* Create user manuals, training guides, and other support materials to aid in the onboarding and ongoing education of staff regarding material specifications.
Special Job Requirements:
* College Degree in supply chain management, business, biology, or related field
* 2+ years' experience in a Specification / Technical Writer role within a GMP environment
* Experience with material management and/or material specifications
Additional Preferences:
* Past experience with supply chain operations within the pharmaceutical industry
* Excellent organizational skills with high attention to detail.
* Ability to collaborate effectively with cross-functional teams and communicate complex information to diverse audiences.
* Ability to manage multiple projects and deadlines simultaneously.
* Lead, manage, and facilitate an organized approach to capturing and communicating specification status, required actions, and responsible parties required to ensure timely effectiveness of specifications.
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.
By submitting your resume and details, you are declaring that the information is correct and accurate.
Auto-ApplyAdvancement Content Creator
Writer job in Indianapolis, IN
Department: Advancement
Position Type: Full Time
Hourly or Salary: Hourly
Pay Range: $22-$24.50
The Advancement Content Creator will serve as a valuable team member within the Member and Donor Experience team. The successful candidate will be responsible for organizing and providing communications initiatives necessary for a successful member and donor experience, including but not limited to Annual Report, Donor Publication, Appeal Letters, Proposals, and other forms of communication to members and donors. The Content Creator will also work collaboratively with Marketing and Communications department to strategically align on communications across all Newfields stakeholders, and manage the Advancement strategic communications plan and calendar.
Responsibilities
The following responsibilities describe the general nature of work for employees in this position, but this is not intended as an exclusive or all-inclusive inventory.
Annual Report Duties
Serve as the coordinator for Newfields Annual Report, which includes scheduling meetings, liaising with creative vendor on schedule creation and information share.
Securing proper routing of drafts for approval, insuring edits are resolved.
Work collaboratively with Legal and Exhibitions to secure proper and correct Rights & Reproductions, and credit lines are accurate.
Provide accurate mailing list to printing vendor for distribution.
Provide internal partners copies of the Annual Report as needed.
Donor Publication Duties
Serve as the editor of the annual Donor Publication, which includes working collaboratively with internal and external partners to insure delivery of assigned stories.
Work collaboratively with leadership to develop story content.
Provide guidance to staff and writers to improve readability based on brand guidelines and audience.
Schedule interviews with staff and donors as needed.
Read copy and proof to detect and correct errors, ensuring adherence to Newfields writing standards and brand guidelines.
Verify facts, dates, and statistics.
Work collaboratively with Legal and Exhibitions to secure proper and correct Rights & Reproductions, and credit lines are accurate.
General Correspondence Duties
Strategically plan and manage the Advancement Communications Calendar
Write and distribute Appeal Letters, Renewals, and Announcements according to communication plan and event schedule.
Provide communication support to Development through the preparation of Stewardship Reports and Proposals as needed.
Work collaboratively with Marketing to develop content and editing support of monthly eNewsletter.
Write and distribute one-off communications to donors and/or members as instructed by leadership.
Other Duties
Represent MADE at internal standing meetings as assigned.
Provides event support when needed.
Perform other duties as assigned by leadership.
To perform the job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required Skills
Excellent written and verbal communication skills.
Proficient in Microsoft Office Suite. Experience with email marketing platform, such as Delivra or Mail Chimp preferred.
Ability to maintain a professional demeanor, particularly when dealing with members, donors, and external constituents.
Ability to multitask efficiently, prioritize work and meet deadlines.
Attention to detail to maintain consistency and accuracy in work.
Ability to be flexible, resourceful, and collaborative.
Ability to work cross-departmentally to carry out projects and resolve problems.
Ability to comprehend and apply Newfields brand standards and writing guidelines.
Education and/or Experience
Undergraduate degree in Journalism, English, or other related field.
Two to three years of related field experience.
Art History and/or philanthropy knowledge is desirable.
Physical Demands of Work Environment
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical demands:
While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear; taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
Work environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of the position. The noise level in the work environment is usually moderate.
Technical Writer
Writer job in Greenfield, IN
Must Have Technical/Functional Skills This role will focus on functional modules such as UI Benefits(claim filing, etc) and employer tax, and work closely with BAs, developers, QAs to produce clear, user-friendly materials, including step-by-step guides and system design artifacts. You will also interact directly with the system to capture screenshots, document scenarios, and contribute to the success of training efforts.
Roles & Responsibilities
* Proficiency in using Microsoft Office Suite, Adobe Acrobat, and documentation platforms such as SharePoint, JIRA, Confluence.
* Strong command of English with excellent writing, editing, and formatting skills.
* Preferred: Experience with Unemployment Insurance systems, especially in areas related to claims, employer tax, or benefits.
Salary Range: $100,000 $110,000 Year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.
#LI-DNI
IT Technical Writer
Writer job in Indianapolis, IN
Mindlance is a national recruiting company which partners with many of the leading employers across the country. Feel free to check us out at ************************* Its a simple route driver job and company will be providing the car.
Job Description
Job Details:
Produce system documentation from the content provided by subject-matter experts (SMEs). Assist SMEs in creating quality documentation by providing guidance on format. Supports and/or contributes to the design, development, and delivery of end user training and/or procedures. Revise documents to support the resolution of incidents (Trouble Tickets) within committed service levels. Revise documents in support of the execution of change requests in compliance with local change control procedures. Operate with a quality mindset (capable, in control, compliant, and continuously improving).
Primary Position Responsibilities (major or daily tasks):
Documenting business and IT processes and systems. This resource must have the ability to quickly comprehend complex business processes and IT terminology in order to participate in technical discussions and walk away with a clear understanding of what was discussed and be able to document that understanding.
Requirements / have to haves not listed elsewhere:
This resource must have the ability to quickly comprehend complex business processes and IT terminology in order to participate in technical discussions and walk away with a clear understanding of what was discussed and be able to document that understanding. The individual must have strong communication and writing skills.
Qualifications
Requirements / have to haves not listed elsewhere:
This resource must have the ability to quickly comprehend complex business processes and IT terminology in order to participate in technical discussions and walk away with a clear understanding of what was discussed and be able to document that understanding. The individual must have strong communication and writing skills.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Senior Technical Illustrator- Writer
Writer job in Indianapolis, IN
←Back to all jobs at COMLUX AMERICA LLC Senior Technical Illustrator- Writer
Interpret mechanical system and electrical engineering drawings including their accompanying substantiation reports so that illustrations can be produced and supplemental instructions for continued airworthiness including but not limited to aircraft crew operating manuals and safety briefing information, can be written in support of receiving a regulatory approval for a modified aircraft. Duties shall be split between illustrating and technical writing, as workload requires.
EXAMPLES OF ESSENTIAL JOB FUNCTIONS:
1. Strong ability to read and understand engineering drawings is key
2. Review all systems and technical drawings to create procedural manuals for each component, system, interior configuration etc., which are customized specifically for each aircraft
3. Translate technical information into clear, readable documents to be used by technical personnel
4. Organize material and complete writing assignment according to set standards
5. Develop and update corporate documentation and forms as tasked by the manager
6. Coordinate with the production team to access the aircraft in order to validate the written procedural steps prior to aircraft close-up
7. Create simple illustrations to support manuals
8. Take digital photographs for reference and incorporating into projects as required
9. Quality check the hard copy and electronic files of the documents to ensure all requirements are met prior to submitting documents to external in-process review and final delivery
10. Provide estimated scope of work for cost preparation
11. Prepare and maintain project schedules as required
12. Advise and assist Technical Writers as needed
13. Maintain configuration control of files for historical purposes
14. Performs other related duties as assigned
MINIMUM QUALIFICATIONS, EDUCATION, EXPERIENCE, LICENSES, ETC:
1. BS Degree in Industrial Technologies, graphics, technical arts or Aeronautics preferred with equivalent technical writing work experience
2. 6+ years of experience as an aviation technical writer or illustrator
3. Working knowledge of Microsoft Office
4. Working knowledge of Adobe Frame Maker and Illustrator
REQUIRED SKILLS AND ABILITIES:
1. Excellent procedural technical writing skills with thorough knowledge of English grammar and punctuation
2. Ability to assimilate technical concepts quickly and to produce accurate procedural instructions
3. Demonstrated experience in designing and producing simple illustrations for technical documentation
4. Must have excellent organizational skills with the ability to work independently but can seek guidance when necessary
5. Ability to meet tight deadlines and adjust to changing priorities
INTRODUCTORY PERIOD
Please note that you will be on a ninety (90) day probation, during which your performance will be evaluated. Comlux shall periodically review your performance and ability to perform each of the essential functions of your position identified above prior to the expiration of the probationary period. If you fail to pass the performance review or display behavioral issues or fail to meet expectations for reporting to work on time as scheduled, you shall be considered as having failed to qualify for continued employment during the probationary period, in which case Comlux shall be entitled to immediately terminate your employment.
Please visit our careers page to see more job opportunities.
Customs Entry Writer
Writer job in Indianapolis, IN
Job Description
Customs Entry Writer Salary - $50k to $65k - depending on experience Excellent Company benefits. 401k, Dental insurance, Health insurance, Life insurance, Paid time off, and Vision insurance. Must have one plus years' current experience of Customs Entries working in the Freight Forwarding industry
Must have a valid Visa to work in the USA
Sorry, Visa/sponsorship is not available.
The client
Our client as a global leader in logistics and supply chain management, excels in providing comprehensive freight forwarding solutions across international borders. With a robust network of partners and cutting-edge technology, they ensure seamless, efficient, and cost-effective transportation of goods worldwide
The successful candidate in this position will possess key skills and experience which include knowledge of international import transportation, import brokerage procedures, U.S. Customs and Border Protection (“Customs”), and Participating Government Agency (“PGA”) requirements including the clearance process, classification and valuation.
This position requires excellent organizational skills with the ability to multi-task along with the knowledge to produce accurate workflow in a fast-paced, high-pressure freight forwarding operations environment, while positively contributing to the success of the team.
This role primarily requires the individual to manage accounts from A to Z, prepare all documentation necessary to clear merchandise through Customs and any applicable PGA, provide excellent, thorough, and prompt customer service and perform any tasks assigned by the Manager, Supervisor, or Team Lead that meets the needs of the team and department.
Responsibilities
Prepare Arrival Notices, Opening files -file set-up
Inputting data information obtained from Agents and freight forwarders
File Customs entries for clearance
Work with Customs and other Government agencies to obtain release
Customer service
Billing of files
Very first involvement will be to do with ISF filing (import security filing)
Bill of lading - tells you title of the goods, tells if the customer has paid the supplier, how much it is worth, and any extra regulations involved with that particular cargo.
Customs entry will be filed to the PGA (PARTNER GOVERNMENT AGENCY) and will need to comply to government guidelines to release the cargo.
Works with the CBP- (Custom Border Protection)
Works with quarantine issues
Deals with fees and duty taxes
Some documents to file to the US customs -commercial packing list , bill of lading ,certificate of origin , liaise with the PGA guidelines to clear the goods.
Signs documents on behalf of clients, using power of attorney.
Technical Writer
Writer job in Indianapolis, IN
Technical Writer needs 3+ years technical writing experience
Technical Writer requires:
Technical writing
SOPs
Analyze
Training material
Develop and Edits standard operating procedures, user tools, training materials, glossary content and global standards.
Work with teams to document action plans to ensure SOP compliance, which includes writing and editing of documentation.
Route documentation through review and approval processes in the document management system.
Analyze existing documentation to ensure it is updated, reviewed, and maintained as appropriate with subject matter experts.
Adhere to appropriate quality and verification-including SOPs and makes recommendations on system documentation.
Organize existing and new documentation.
If expertise in technical writing, then will need to coach and train the other document controllers on technical writing concepts and instruction.
Suggest appropriate formatting for documentation.
Serves as a point person for documentation advice and help
Service Writer Internal / External
Writer job in Bunker Hill, IN
This is a full-time & year-round position
Full-Time Position
The Service Writer supports the Service Department and is responsible for preparing work orders, ordering parts, receiving parts, stocking parts bins, claiming warranties, and providing exceptional customer service to RV Dynasty Customers.
Essential Duties And Responsibilities
Provide our customers with a positive service experience & assure customer satisfaction.
Schedule, coordinate, and supervise service orders with technicians, from customer drop off to customer pick up.
Keep detailed, accurate records on service work, warranties, internal billing, etc.
Ensure that work orders are cashiered in an accurate and timely manner.
Track warranty work orders and warranty submissions and ensure they are billed and paid in a timely manner.
Clearly communicate billing, inventory, warranty, or customer service issues to the Shop Foreman
Responsible for walking through the services performed on the customers RV with each customer.
Generate additional service work to drive sales and revenue to the service department.
Maintain a safe and clean work environment.
Promote the RV Dynasty brand and other product offerings.
Other tasks required by the manager.
Knowledge, Skills, Abilities
To perform the job successfully, an individual should demonstrate the following competencies:
Mechanical: Able to understand the basic mechanical and electrical systems on watercraft and RVs and communicate issues to employees and customers.
Selling: the ability to promote and sell the service centers products and services with a full understanding of what each product does and is, in order to communicate that with customers
Sr. Specification Writer
Writer job in Fishers, IN
Description Supply Chain Specification Writer Summary INCOG BioPharma Services is seeking an experienced and detail-oriented Specification Writer to join our Supply Chain Team. This role is crucial for translating complex technical data into clear, accurate, and accessible documentation. The Specification Writer will work closely with Supply Chain, External Vendors, Clients and other cross-functional teams to create comprehensive documentation that supports new material specifications and updates for existing specifications, ensuring that all materials meet regulatory and quality standards. Essential Job Functions:
Develop, author, and maintain material specifications, ensuring that the information is clear, detailed, and usable by both technical and non-technical stakeholders.
Ensure all documentation is compliant with GMP standards and meets regulatory requirements
Work closely with Supply Chain, vendors, Quality, project teams, and clients to gather necessary technical information, facilitate effective communication, and ensure that all documentation reflects the latest material information and stakeholder feedback.
Understand material requirements, track progress of specifications, and support prioritization to ensure operational readiness.
Support escalation, documentation, and generate action items for path forward when specification approval does not align with operational timelines or requirements.
Establish and maintain documentation standards to ensure consistency across all technical documents. Continuously review and update documents to reflect process improvements, new requirements, and regulatory changes.
Create user manuals, training guides, and other support materials to aid in the onboarding and ongoing education of staff regarding material specifications.
Special Job Requirements:
Education: College Degree or Equivalent experience demonstrated in this field
Experience: 2-4 years previous experience in a Specification / Technical Writer role (pharma preferred).
Additional Preferences:
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.
Ability to manage multiple projects and deadlines simultaneously.
Lead, manage, and facilitate an organized approach to capturing and communicating specification status, required actions, and responsible parties required to ensure timely effectiveness of specifications.
INCOG's Benefits:
Paid time off, based on tenure.
11 observed holidays + 1 floating holiday.
Choice to elect for pet insurance.
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.
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. By submitting your resume and details, you are declaring that the information is correct and accurate.
Auto-ApplyINCOG BioPharma Services Careers - Deviation Writer
Writer job in Fishers, IN
INCOG BioPharma Services is seeking an experienced and detail-oriented Deviation Writer to join our Manufacturing Engineering 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.
Essential Job Functions:
* 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.
Special Job Requirements:
* 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.
Additional Preferences:
* 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.
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.
Auto-ApplyTechnical Writer
Writer job in Indianapolis, IN
Technical Writer needs instructional design, performance technology, or quantitative discipline (i.e., Sciences, Finance, Econometrics, Statistics, Engineering or Computer Sciences)
Technical Writer requires:
Bachelors degree or higher in education, instructional design, performance technology, or quantitative discipline (i.e., Sciences, Finance, Econometrics, Statistics, Engineering or Computer Sciences)
Demonstrated excellence with standard IT tools as Microsoft 365, particularly Excel and PowerPoint.
Demonstrated ability in communication, conflict resolution, using good judgment, and managing complexity.
Demonstrated ability to establish strong business relationships.
Good interpersonal and communication skills, fluent (verbal and written) in English.
Ability to operate effectively in an international matrix environment, with ability to work across time zones.
Knowledge of and experience with the Microsoft Power Platform.
Experience with SuccessFactors, Veeva Vault, or other similar learning/ document management systems.
Human Performance Improvement (HPI) Certification.
Working knowledge of and/or experience in a regulated environment.
Demonstrated ability in communication, conflict resolution, using good judgment, and managing complexity.
Demonstrated ability to effectively work in a collaborative environment and build trust with internal and external business partners.
Demonstrated ability to scope and lead projects.
Demonstrated success in influencing without authority.
Effective problem-solving skills to evaluate and resolve business and organizational problems.
Technical Writer
Writer job in Indianapolis, IN
←Back to all jobs at COMLUX AMERICA LLC Technical Writer
Interpret mechanical system and electrical engineering drawings including their accompanying substantiation reports so that supplemental instructions for continued airworthiness including but not limited to aircraft crew operating manuals and safety briefing information, can be written in support of receiving a regulatory approval for a modified aircraft.
EXAMPLES OF ESSENTIAL JOB FUNCTIONS:
1. Strong ability to read and understand engineering drawings are key
2. Review all systems and technical drawings to create procedural manuals for each component, system, interior configuration etc., which are customized specifically for each aircraft
3. Translate technical information into clear, readable documents to be used by technical personnel
4. Organize material and complete writing assignment according to set standards
5. Develop and update corporate documentation and forms as tasked by the manager
6. Coordinate with the production team to access the aircraft in order to validate the written procedural steps prior to aircraft close-up
7. Create simple illustrations to support manuals
8. Take digital photographs for reference and incorporating into projects as required
9. Quality check the hard copy and electronic files of the documents to ensure all requirements are met prior to submitting documents to external in-process review and final delivery
10. Maintain configuration control of files for historical purposes
11. Performs other related duties as assigned
MINIMUM QUALIFICATIONS, EDUCATION, EXPERIENCE, LICENSES, ETC:
1. BS Degree in Industrial Technologies, Technical Writing, or Aeronautics preferred with equivalent technical writing work experience
2. 3+ years of experience as an aviation technical writer or illustrator
3. Working knowledge of Microsoft Office
4. Working knowledge of Adobe Frame Maker, Illustrator and RoboHelp
REQUIRED SKILLS AND ABILITIES:
1. Excellent procedural technical writing skills with thorough knowledge of English grammar and punctuation
2. Ability to assimilate technical concepts quickly and to produce accurate procedural instructions
3. Demonstrated experience in designing and producing simple illustrations for technical documentation
4. Must have excellent organizational skills with the ability to work independently but can seek guidance when necessary
5. Ability to meet tight deadlines and adjust to changing priorities
INTRODUCTORY PERIOD
Please note that you will be on a ninety (90) day probation, during which your performance will be evaluated. Comlux shall periodically review your performance and ability to perform each of the essential functions of your position identified above prior to the expiration of the probationary period. If you fail to pass the performance review or display behavioral issues or fail to meet expectations for reporting to work on time as scheduled, you shall be considered as having failed to qualify for continued employment during the probationary period, in which case Comlux shall be entitled to immediately terminate your employment.
Please visit our careers page to see more job opportunities.
INCOG BioPharma Services Careers - Enterprise Systems Technical Writer
Writer job in Fishers, IN
We are seeking an Enterprise Systems Technical Writer who is agile, collaborative, and passionate about technology and systems development. This role blends technical writing expertise with core business systems analysis skills. The Enterprise Systems Technical Writer will work closely with IT, Quality, Validation, and project teams to quickly learn new processes and systems, then translate that knowledge into clear, accurate documentation-including SOPs, validation documents, and training materials-to support the deployment and adoption of new enterprise systems. You'll be instrumental in documenting new enterprise systems, ensuring GMP compliance, and enabling our teams to adopt technology that drives operational excellence.
Essential Job Functions:
* Rapidly learn new enterprise systems and business processes through collaboration with subject matter experts and hands-on exploration.
* Develop, update, and maintain high-quality documentation such as Standard Operating Procedures (SOPs), validation protocols, user guides, and training materials for IT and business systems.
* Partner with program managers, subject matter experts, quality assurance, and validation to capture requirements, workflows, and system capabilities.
* Translate complex technical and business concepts into clear, user-friendly documentation for diverse audiences across the organization.
* Support system deployment and adoption by creating materials that facilitate training and onboarding for personnel.
* Ensure documentation aligns with regulatory requirements, industry standards (e.g., GxP, Data Integrity, Good Documentation Practices), and internal quality guidelines.
* Participate in system validation activities, assisting with the creation and review of validation documentation.
* Collaborate with stakeholders to identify documentation needs and continuously improve content based on feedback and evolving business processes.
* Maintain version control and accessibility of documentation assets to ensure reliability and security.
Special Job Requirements:
* 3+ years of experience in technical writing, preferably in IT or regulated environments.
* 2+ years of experience in business systems analysis or related roles.
* Demonstrated ability to quickly learn new systems and processes.
* Experience developing SOPs, validation documents, and training materials.
* Experience with CSV documentation in pharmaceutical, biotech, or medical device industries.
* Familiarity with software development life cycle, system validation, and compliance standards.
* Excellent written and verbal communication skills.
* Proficiency with documentation tools such as Microsoft Office Suite, Visio, or similar workflow mapping tools.
* Experience creating visual documentation (process flows, system diagrams, user interface mockups
* Bachelor's degree in Computer Science, Life Sciences, Engineering, Technical Communication, or equivalent experience.
Additional Preferences:
* Experience with enterprise systems is a plus (ERP, LIMS, QMS).
* Advanced degree or certification in Informatics, Technical Writing, or Business Analysis is desirable.
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.
By submitting your resume and details, you are declaring that the information is correct and accurate.
Auto-ApplyTSMS Tech Writer
Writer job in Fishers, IN
The Technical Writer is crucial for translating complex technical processes and data into clear, accurate, and accessible documentation. The Technical Writer will work closely with the MSAT engineers and other cross-functional teams to create comprehensive documentation that supports tech transfer, process validation, GMP floor support, and continued process verification, ensuring that all materials meet regulatory and quality standards.
Essential Job Functions:
• Develop, author, and maintain a wide variety of technical documents, including but not limited to Process Flow Diagrams, Summary Reports, Process FMEAs, Master Batch Records, Bill of Materials, and Processing Forms, ensuring that the information is clear, detailed, and usable by both technical and non-technical stakeholders.
• Ensure all documentation is compliant with GMP standards and meets regulatory requirements, particularly for Process Performance Qualification and Continuous Process Verification.
• Work closely with MSAT engineers, project teams, and clients to gather necessary technical information, facilitate effective communication, and ensure that all documentation reflects the latest process developments and changes.
• Translate technical data and process monitoring results into comprehensible reports, identifying trends, proposing actions, and supporting troubleshooting efforts with clear, actionable documentation.
• Establish and maintain documentation standards to ensure consistency across all technical documents. Continuously review and update documents to reflect process improvements, new technologies, and regulatory changes.
• Create user manuals, training guides, and other support materials to aid in the onboarding and ongoing education of staff regarding GMP manufacturing processes and protocols.
Special Job Requirements:
• Associate's degree in an English major or in scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Biochemistry, Biotechnology, Engineering). A bachelor's degree is preferred.
• Minimum of 0 - 3 years of experience in technical writing within a GMP environment, preferably in the pharmaceutical, biopharmaceutical, or biotechnology industries.
Additional Preferences:
• 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).
• Ability to manage multiple projects and deadlines simultaneously.
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.
Auto-ApplyManufacturing Technical Writer
Writer job in Indianapolis, IN
Manufacturing Technical Writer needs 2+ years' tech writing , quality assurance experience
Manufacturing Technical Writer requires:
Bachelors Degree or Work Experience
Experience in Technical Writing
Strong communication and attention to details skills
Ability to work independently and in a team environment
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
8-hour days Monday Friday on site is required - work outside of standard hours may be required
Onsite position at manufacturing plant, will need to wear safety glasses and steel toe shoes.
Manufacturing Technical Writer duties:
Create / revise, SOPs, training, and related documents, ensuring all documents are delivered on-time, follow established format and template, and are compliant with corporate / local policies to meet all regulatory requirements and commitments
Working with business functions and subject matter experts, participate in usability testing and or compiling revision comments for SOPs and training documents as required
Participate in and or facilitate the review / approval process (including meetings) required to revise, create, and route the documents thru approval in EDMS (electronic document management system)
Anticipate and adjust for project / program issues, escalating as appropriate
Ø