USA-Technical Writer II (Scientific)

Post Date

Feb 22, 2023

Location

Swiftwater,
Pennsylvania

ZIP/Postal Code

18370

Job Type

Contract

Req #

VMS-SAN-SNFIJP00007502

Pay Rate

$34 - $42 (hourly estimate)

Job Description

KEY RESPONSIBILITIES:

Responsible for designing developing and updating required technical documentation technical writing/editing for all types of documentation produced within a modern software development environment.

Strong knowledge of word processing software strong writing and analytical skills to document software capabilities Tracking and reviewing change control documentation.

Review current documents- incorporate comments from Manager Navigate through sanofi Geode or similar documentation system utilizing current templates Notify manager of workflow status and issues Incorporate comments from team members and provide status to manager on review and approval workflow Follow up with team members on comments Complete Annual Audit Trail for PDW and Shop Floor Data and Experience in technical writing in validation environment.

Support non-conformance issues related to change controls deviations corrective Action-Preventative Actions CAPAs and memos as needed. Write/revise SOPs and SWIs to align to program strategies under cGMP environment.

SPECIFIC TASKS:

Support Extractables and Leachables EL Filter Validation Cleaning and filter validation documentation.

Participate in Gemba/ shop floor walk through to learn about product processes and / or interview stakeholders to collect data on non-conformance issues.

Comply with cGMP health and safety guidelines and other internal and external quality and regulatory guidelines.

Assist in the technical transfer and industrialization of process from MTECH to the cGMP manufacturing facilities across the site.

OTHER PREFERRED ATTRIBUTES

Proficient in MS Word Excel PowerPoint database creation and Outlook Self-motivated and willing to be proactive in resolving issues

Must possess sound interpersonal and information gathering skills being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment effectively interacting with others

Behaves according to company values and competencies.

Forward thinking with an attitude of collaboration optimization efficiency continuous improvement.

Effectively communicates successes constraints conflicts solutions and actions for resolution.

Proactively resolves conflicts removes roadblocks to execution within sphere of influence escalates to functional management when appropriate.

Fosters relationships with partners and customers in order to achieve technical objectives.

Strong analytical and technical writing skills relevant work experience extensive industry experience in a cGMP/environment is a plus

Exceptional attention to detail and multi-tasking abilities is a plus

QUALIFICATIONS:

Adequate experience in industry to perform the required tasks or a Bachelor's degree in Chemistry/Biochemistry/Biological Science/other science degree with 0-3 years or Masters degree in Chemistry/Biochemistry/Biological Science with 0-1 years.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.