Technical Writer (ONSITE- DAY SHIFT)

Overview

On Site
Depends on Experience
Contract - W2
Contract - 18 Month(s)

Skills

Technical writing
GMP manufacturing
pharmaceutical manufacturing
biopharmaceutical manufacturing
process scale-up
process transfer
batch record writing
data capture forms
automated equipment methods
process documentation revision
change control records
risk assessments
CAPA
effectiveness verification records
real-time problem solving
troubleshooting
project team participation
process equipment compatibility
SOP revision
batch summary generation
process deviation investigation
root cause analysis
regulatory agency knowledge
process validation
interdepartmental collaboration.
CGMPs
Technical Services (TS)
Manufacturing Science and Technology (MSAT
MS&T)
document generation
change control (CC)
corrective action and preventive action (CAPA)
batch record (BR
MBR)
GMP oligonucleotide pharmaceutical manufacturing
process documentation
manufacturing batch data evaluation.

Job Details

Please note that this is a 6-18 months contract position.

Required Qualifications:

Experience with CGMPs
Experience with pharmaceutical/biopharmaceutical manufacturing is required, especially for a temporary position, as it would be challenging to get someone up to speed on regulatory expectations for pharmaceutical processes in the limited time projected for the role.
Key terms to look for in resumes include Technical Services (TS) or Manufacturing Science and Technology (MSAT or MS&T), as these are direct analogues to the current role.
Experience with document generation, including:
Change control (CC)
Corrective action and preventive action (CAPA)
Batch record (BR or MBR)The primary focus for this position will be writing and/or reviewing the various documents listed above.

Job Description:

The day-to-day responsibilities for this role may vary, but it will primarily include:

Writing and reviewing batch records for GMP oligonucleotide pharmaceutical manufacturing
Writing and reviewing change controls for these processes
Collecting and evaluating manufacturing batch data


Applicants must provide their phone number. Reference job number A4479.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.