Company: Apex Systems
Posted on: June 23, 2022
***Apex Systems has a great Opportunity with a local client for
a Technical Investigation Writer. Do you have experience in Writing
Investigations? Have you worked in the Pharmaceutical industry
before? If so, please take a look at the description below and
reach out to us!! Please send resumes to Serena Morris at
email@example.com***Job SummaryThe position of Technical
Investigation Writer is responsible for leading investigation
activities, identifying root cause failure modes, developing
failure specific Corrective and Preventative Actions (CAPAs), and
writing deviation investigation reports supporting non-conforming
(process and procedural) events. To be successful, this individual
effectively leverages key investigational tools such as; root cause
analysis (RCA), 5-why analysis, and/or fishbone diagrams. Write,
edit and review laboratory procedures for accuracy. This role will
engage/communicate with all levels of site leadership on the status
of all investigations. Job RequirementsEducation and
- Bachelor's Degree required, preferably in Sciences (e.g.,
- Minimum 4 years relevant experience in a regulated GMP
environment; pharma industry preferred
- 1-3 years relevant technical writing experience
- Six Sigma or Lean certification a plus
- Manufacturing/Laboratory quality assurance experience
- Strong communication/facilitation experienceKnowledge, Skills
- Understand Code of Federal Regulation and GMPs.
- Advanced project management skills are routinely practiced for
multiple concurrent projects of moderate complexity.
- Ability to establish clear priorities, work efficiently under
pressure, handle multiple projects and meet deadlines.
- Strong verbal and written communication skills; ability to
interface with all levels of the organization.
- Ability to learn and retain technical information.
- Experienced in most aspects of drug development and lifecycle
- Has substantial breadth/depth of technical acumen in multiple
techniques and can understand their application in context of
pharmaceutical services offerings.
- Mathematical and scientific reasoning ability.
- Capable of rapid learning of unfamiliar principles or
techniques with minimum training.
- Ability to interpret a variety of instructions furnished in
written, oral, diagram, or schedule form.
- Ability to work effectively under pressure to meet
- Well organized with ability to handle multiple activities
- Ability to communicate moderately complex technical information
to non-technical audiences.
- High personal credibility with peers and subordinates.
- Lead by example according to our values and culture.Physical
- Be accessible to laboratory, manufacturing areas and office
staff and to use required office equipment. Specific vision
requirement includes reading of written documents and use of
computer monitor screen frequently.
- Individual may be required to sit, stand, walk regularly and
occasionally lift 0-50 pounds.Working Conditions and Environment:
- Office area, laboratory and manufacturing areas.
Keywords: Apex Systems, Cary , Technical Writer, Engineering , Morrisville, North Carolina
Didn't find what you're looking for? Search again!