Description
VISA SPONSORSHIP NOT AVAILABLE
Kashiv BioSciences is a fully integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. We are looking for a Documentation Specialist to join our Piscataway NJ Quality Management team.
This is an exciting opportunity to work closely with Management on all aspects of Quality related to our pharmaceutical manufacturing site. Will work as a member of the Quality team to ensure GMP documents & quality standards.
ESSENTIAL RESPONSIBILITIES
- Perform Issuance, Archival and maintain of all GMP documents like SOP, Batch Record, Forms.
- Maintain OOS, Deviation, CCF, CAPA log
- Review Cross Functional departments SOP
- Perform batch related sampling
- Assist in batch record review
- To train cross functional team on GDP and cGMP
- To perform additional work assigned by supervisor as and when required
Requirements
Education
- BS or MS in a scientific discipline or equivalent and a minimum 3 years of related experience.
- Expert knowledge of scientific principles and concepts.
Special Skills
- Ability to read and interpret all quality documents. Ability to understand GMP requirements.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Effective verbal and written communication and reporting writing skills
Work Environment & Physical Demands
General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel may be involved.
This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.
Kashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.
Skills Required
- BS or MS in a scientific discipline or equivalent
- Minimum 3 years of related experience
- Expert knowledge of scientific principles and concepts
What We Do
Kashiv BioSciences is a fully-integrated biopharmaceutical company with global R&D, clinical, manufacturing, regulatory, and IP capabilities, focusing on developing and manufacturing biosimilars and complex peptide medicines to improve access to important therapies.
