USA-Technical Writer II (IT) - Contract

TalentBurst, Inc.

Swiftwater, PA

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JOB DETAILS

SALARY

$47.02–$48.02 Per Hour

SKILLS

Biotech and Pharmaceutical, Communication Skills, Current Good Manufacturing Practice (cGMP), Editing, GMP (Good Manufacturing Practices), Interpersonal Skills, Laboratory Information Management System (LIMS), Maintain Compliance, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, Microsoft Visio, Microsoft Word, Presentation/Verbal Skills, Project Tracking, Quality Control, Regulatory Compliance, Regulatory Requirements, Safety Compliance, Safety Training, Standard Operating Procedures (SOP), Team Player, Technical Writing, Time Management, Validation Plan, Writing Skills

LOCATION

Swiftwater, PA

POSTED

3 days ago

Job Title: USA-Technical Writer II (IT))
Location; Swiftwater, PA
Duration: 6 Months

Note: Local candidates only, full onsite No extension at this time Free parking onsite MS, PHD candidates welcomed. Additional years of experience will be accepted.

Must have Experience:
Min Bachelor's degree and 2+ years of relevant experience
Experience with LIMS, iLMS
Ability to work Independently
Strongly Preferred biotech pharma experience.

Nice to Have:
Qualipso
Experience with methodologies: CPV, Continuous Process Verification have
Sequel

Role: QC OneLIMS Data Setup Specialist

Description:
The OneLIMS EM project technical writer is responsible for supporting on-time implementation of OneLIMS EM global system for the Swiftwater, PA site. The candidate must perform tasks in an efficient, cGMP compliant, and safe manner. Success in this position requires the individual to be adaptable and react quickly to changing priorities in a high-stress environment. The candidate is required to complete Safety and Compliance training and associated training modules.

Primary Responsibility: alignment of CPV program with global standards & transfer of Process monitoring trend limits to OneLIMs

Key Responsibilities:
Design, develop, and update required technical documentation.
Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements.
Create Training slides and content.
Support Future state process mapping.
Organize, track and plan master data review.
Track and mange project specific deliverables.

Qualifications:
Bachelor's Degree required.
Prior experience with quality applications, such as Veeva, LIMS.
Prior experience with MS Word, Excel, Powerpoint, Visio and Outlook.
Prior work experience in a good manufacturing practices (GMP) environment.
Must possess sound interpersonal and information gathering skills, be able to relate well to others and have the ability to work in a team environment, effectively interacting with others.
Excellent verbal and written communication skills.
Minimum of 2 + years of related experience.

Education: BS in science or engineering

Preferred: familiarity with One LIMs, Qualipso, and CPV programs.

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About the Company

TalentBurst, Inc.

For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.

Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!

COMPANY SIZE

5,000 to 9,999 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2002

WEBSITE

http://www.talentburst.com/