Our partner an equal opportunity employer, is welcoming candidates of all backgrounds and abilities for a DPI Technical Writer position in Hauppauge, NY.
Responsibilities:
- Work Hours/Shift: Monday to Friday (day shift), with possible overtime and Saturdays.
- Prepare and review Change Controls, Technical Deviations, Methods, Specifications, COAs, Batch Records, Validation protocols/reports.
- Conduct focused time-studies to support packaging operations.
- Support technical writing in DPI Unit investigations, Corrective Action Preventive Actions (CAPAs), change controls, and validation activities.
- Apply process improvement strategies and lean techniques for packaging operations.
- Participate in crafting and refining ideas, cultivating sources, and developing technical documents.
- Perform and direct data mining and analyze results to provide recommendations or conclusions.
- Review and edit content for compliance, clarity, and proper use of terminology.
- Follow documented SOPs for creating and storing documents.
- Work independently and collaboratively.
- Collect, organize, and analyze data for recommendations and performance monitoring.
- Perform administrative functions as directed by Management.
- Actively participate in Root Cause Analysis to identify areas for improvement.
- Enforce safety regulations and ensure a clean working area.
- Adhere to Safety, Health, and Environmental policies.
- Work under general supervision and in a team environment.
- Exercise appropriate professional judgment.
- Work in a pharmaceutical manufacturing setting.
- Perform other duties as required by Manufacturing Management.
Requirements
- BA/BS degree in a related field of study from an accredited college/university required.
- One (1) to three (3) years of direct work experience in pharmaceutical manufacturing. Preference for candidates with experience in generic pharmaceutical manufacturing.
- Skills/Competencies:
- Advanced Analytical Mathematical Skills.
- Ability to communicate department needs and agenda to other groups.
- Excellent communications and presentation skills – written and verbal; fluent in English.
- Strong knowledge in Microsoft Office applications (Word, Excel, PowerPoint, etc.) and PDF editing.
- Good understanding of cGMP, current technologies, and current FDA guidelines.
- Able to prioritize, plan, and work under tight schedules and deadlines.
- Strong documentation and technical writing skills.
- Clear and concise communication, both orally and in writing.
- Strong command of written and verbal English.
Benefits
- Salary Range: $18/hr – $25/hr
- 401(k) savings plan with matching
- Health insurance (medical/dental/vision)
- Health savings account (HSA)
- Flexible spending account (FSA)
- Paid time off (vacation/sick/flex time)
- Paid holidays
- Short-term disability (STD)
- Long-term disability (LTD)
- Parental leave
- Paid and unpaid family leave
- Employee discounts and other benefits.