Technical Writer - Tech Transfer and Validation

Adare Pharma

Vandalia, OH

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JOB DETAILS

SKILLS

Analytical Development, Apple iPad, Biology, Biotech and Pharmaceutical, Business Ethics, Cellular Telephone, Change Control, Chemistry, Clinical Trial, Communication Skills, Continuous Improvement, Contract Manufacturing, Corporate Policies, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Current Good Manufacturing Practice (cGMP), Data Collection, Detail Oriented, Diversity, Document Management, Documentation, Environmental Health, Establish Priorities, FDA (Food and Drug Administration), Finance, GMP (Good Manufacturing Practices), High School Diploma, Human Resources, ISO (International Organization for Standardization), Interpersonal Skills, Investigative Reports, Leadership, Manufacturing, Marketing, Medical Products, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Word, Multitasking, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Process Improvement, Project Execution, Project/Program Management, Purchasing/Procurement, Quality Management, Regulatory Requirements, Reporting Skills, Research & Development (R&D), Safety/Work Safety, Sales, Standard Operating Procedures (SOP), Supply Chain, Support Documentation, Team Player, Technical Research, Technical Support, Technical Writing, Webinar, White Papers, Writing Skills

LOCATION

Vandalia, OH

POSTED

1 day ago

Our Business
Adare Pharma Solutions is a global Contract Development and Manufacturing Organization (CDMO) with locations across North America and Italy. We offer a wide range of manufacturing, packaging, and research and development services. Our clients range from growing biotech firms advancing groundbreaking clinical trials to established pharmaceutical companies producing high volumes of approved, widely used medicines.

By combining top talent from the life sciences industry with modern research and manufacturing technologies, Adare enables clients to deliverpotentially lifesaving medicines in more easily consumable formats - particularly for patients such as infants or the elderly. This is the meaning behind "Transforming Drug Delivery - Transforming Lives."

Our Culture
When it comes to being an employee of Adare, although we are located across multiple countries and come from diverse backgrounds, we work together toward a common purpose. Supported by leadership that is experienced and highly regarded in the industry, we are paving the way for a brighter and better future by attracting top talent from both within and beyond the CDMO space.

In addition to delivering high-quality results for our external clients, we foster a collaborative, client-centric culture internally - one where employees support one another, share knowledge, and encourage each other to bring their best selves to work each day.

Why Come to Adare?
Adare is Private Equity owned and poised for growth. Employees are provided with internal development opportunities to progress within the organization, enhancing their professional skills and industry knowledge through Adare's investment in their growth.

We offer a variety of fields to embark in, including manufacturing, engineering, quality, chemistry, formulations, analytical research and development, finance, supply chain, sales, marketing, project management, human resources, and environmental health and safety. Our benefits package is highly competitive, offering medical, dental, and vision coverage; a retirement plan with company match, paid time off and company holidays, tuition reimbursement with no waiting period, life insurance, pet insurance, Flexible Spending Accounts (medical and dependent care), and disability coverage.

Position

Technical Writer

Location

Vandalia, Ohio

Summary
The Technical Writer reports to the Director of Technical Services and Validation. The essential job function is to assume responsibility for all documentation and procedural activities associated with commercial production and technical transfers, as well as support documentation needs of the R&D scientists. It includes monitoring of existing documents (including, but not limited to: Batch Records, SOPs, OIMs), identifying opportunities for improvement, and implementing both process and/or procedural improvements to further the efforts in the Manufacturing group to continuously improve. It also includes project execution within the department, such as product transfers or changes, in addition to other daily functions needed or requested by the Director of Validation and Technical Services.

Responsibilities

Provide documentation services to the Technical Services department including writing, revising, formatting, processing, filing, and maintaining documents, including electronic files. These documents include, but are not limited to batch production records, SOPs, protocols, and reports.

Be able to draft incident reports, investigation reports, or other quality event (QE) reports.

Support Quality Systems for the Technical Services Department, including CAPA, Change Control, QE tracking/trending.
Work with technical experts to identify and document appropriate Corrective Action, Preventative Action (CAPA) as needed. Responsible for completion of appropriate CAPA documentation.
Act as Electronic Quality Documentation Management System Subject Matter Expert (SME) for the department, assisting and training others as needed.
Responsible for the SOP biennial review process for Technical Services, including SOP revisions within the established timelines, as needed.
Preparation of the Validation Section for Periodic Quality Reviews (PQRs), including data collection, document preparation, and identification of applicable CAPAs as necessary.
Support the process for the generation of scientific papers and technical documentation to promote Adare Technologies and support marketing initiatives
Support the Technical Services and, as appropriate, the Research & Development depts. by drafting Papers, Posters, Whitepapers, Presentations, Webinars, etc.
Support all Continuous Improvement efforts within the department.
Support and promote Safety and cGMP programs, ensuring strict conformance to all current FDA and cGMP guidelines.
Follow and observe all regulatory requirements (GMP's, ISO, FDA, internal policies) applicable to area of responsibility.
Uphold Company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code.
Perform other tasks as required.

Experience, Education, and Skills Required

Minimum High School diploma or equivalency with three to five years of experience technical writing and/or procedure development, preferably in FDA regulated environment OR Bachelor's degree with two to three years of experience technical writing and/or procedure development, preferably in FDA regulated environment.
Proficient with Microsoft Office (Excel, Word, PowerPoint).
Capable of organizing data from multiple sources, extracting key information and writing reports and summaries
Demonstrated ability to write logically and consistently
Strong decision making and problem-solving skills
Excellent interpersonal written and oral communication skills
Ability to thrive in a dynamic and fast-paced environment.
Able to prioritize duties and manage multiple projects from start to finish with minimal supervision.
Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision.
Exceptional attention to detail and excellent organizational skills.

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

PRINCIPALS ONLY
NO AGENCIES OR THIRD PARTIES

Attention Job Seekers and Applicants: Please be aware of attempted recruiting scams. While Adare does conduct virtual interviews for some positions, we do NOT use Skype or Google Meet. If you are contacted by someone regarding a job opportunity, please be vigilant in reviewing the details of any and all correspondence. Here are some things to look out for: bad grammar; font inconsistencies or formatting irregularity: logos not properly sized, stretched out, blurred; numerous different font styles and sizes within the content of an email or letter; company impersonators (postings that mirror a reputable company, but there's no link to the business) mismatched email or website domains, or there is difficulty with locating an address, business phone number, and/or email address, financial requests: Do not provide payment or account credentials as part of the application process. Legitimate companies should not require transfers, checks, gift cards or the wiring of funds as a condition of the application process. Additionally, equipment purchases: be cautious if a company asks you to purchase your own equipment (computers, iPads, mobile phones) and requests you to mail it to their IT department. Applicant Follow-up Questions: Proceed with caution if you receive an application follow-up request that requires you to click on a link to answer additional questions; especially if the questions request personal information such as a social security number. General anonymity: proceed with caution if you can't quickly verify the identity of the poster.

About the Company

Adare Pharma

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