job summary: **IMMEDIATE DIRECT HIRE NEED
for a Technical Documentation Specialist to join our R&D team. This person will liaise between the R&D and Quality teams within our organization.**
location: Monmouth Junction, New Jersey
job type: Permanent
salary: $75,000 - 80,000 per year
work hours: 8 to 4
- Preparation, editing, review, managing, and submitting Quality documents from research & development through commercialization
- Clearly identify document requirements to facilitate new product development
- Review/edit new documents and document revisions to ensure conformity with Quality/Regulatory requirements prior to submission for approval
- Collaborates with cross functional teams and end users to ensure that content generated meets regulatory standards
- 3+ years of experience in controlled document (work instructions, equipment drawings, validation/verification protocols, etc.) initiation/revision.
- Bachelor's or advanced degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical engineering, Biochemistry, or related field
- Experience authoring documents (i.e. SOPS, Study protocols, etc.) required
- Experience in the medical device, pharmaceutical, or biopharma industry
- Strong understanding of product development, GMP, and FDA medical device regulations. Understanding of international regulations is a plus.
- Exceptional written, oral communication, and organizational skills required
- Experience with tech transfer desired
- Ability to work independently and manage work to defined schedules
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.