Job description
Are you looking to be a part of a growing pharmaceutical company? One of our largest clients is currently seeking a
Technical Writer - Production to join their
New Brunswick, New Jersey team. Our client is one of the leading pharmaceutical companies specializing in developing and manufacturing solid dosage products. If you believe you are qualified, we would be excited to connect and discuss this opportunity in more detail.
Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.
Direct Hire
Pay Rate: DoE
Job summary:
Perform investigation’s and assist manufacturing and packaging operations on investigations, Product quality complaints. Assist in cross functional investigations for out of specification (OOS), out of trend (OOT), Laboratory Events, CAPAs, and change controls.
Areas of responsibility:
Required Qualifications:
Additional Skills:
Track wise GDP, GMP, Technical writing, QA Documentation, QA Batch record, Quality System, Archiving, Retrieval, EDMS workflow, Document Life cycle and Audit compliance.
Software skills:
EDMS, Track wise, MS office, MS EXCEL
Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.
#IND1
#ps
Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.
Direct Hire
Pay Rate: DoE
Job summary:
Perform investigation’s and assist manufacturing and packaging operations on investigations, Product quality complaints. Assist in cross functional investigations for out of specification (OOS), out of trend (OOT), Laboratory Events, CAPAs, and change controls.
Areas of responsibility:
- Ensure timely closure of all manufacturing/packaging and Quality Management System records.
- Organize and participate in and reviews of cross functional investigation’s
- Represents Operations at cross-functional meetings.
- Work with process owners and SMEs to implement agreed upon procedural documentation and to develop cross-functional process models
- Collect input from stakeholders and consolidate comments for conflict resolution
- Drive the improvement in established KPI’s / metrics for manufacturing and packaging departments
- Assist operations in responses to any internal audit, corporate audit, or regulatory audit observations involving manufacturing or packaging Control.
Required Qualifications:
- Bachelor's degree (BA/BS) in Life Sciences, Pharmacy, or equivalent required
- Minimum of 4-5 years working in a pharmaceutical environment
- At least 2-3 years technical writing experience within a pharmaceutical manufacturing environment
Additional Skills:
Track wise GDP, GMP, Technical writing, QA Documentation, QA Batch record, Quality System, Archiving, Retrieval, EDMS workflow, Document Life cycle and Audit compliance.
Software skills:
EDMS, Track wise, MS office, MS EXCEL
Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.
#IND1
#ps
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