Job Type
Full-time
Description
Position Summary
Specialist III QA is a regular employee in a full-time exempt position at Kashiv Biosciences. The responsibility for document management lies with this role, including issuance and retrieval of logbooks, laboratory notebooks, issuance of protocol and report numbers, and management of documentation. The employee will support the activities of the QA department in review of QC data and reports, and other reports such as SOPs, CAPAs, Deviations, Change Controls and OOS as needed.
Requirements
Essential Duties & Responsibilities
•Writes, revises, and reviews standard operating procedures (SOPs).
•Conduct reviews of release testing, stability testing, raw material testing, method validations, equipment qualifications and calibrations, technical protocols and reports to ensure compliance with internal procedures and policies, good documentation practices (GDPs), current good manufacturing practices (cGMP), ICH, and other applicable regulations.
•Provide assurance that documentation and testing comply with internal procedures, specifications and cGMP regulations prior to generation of COA for product release.
•Reviews and provides input on lab investigations, deviations, and CAPAs.
•Coordinates with lab analysts to resolve documentation or quality issues and implement corrective or preventive actions as necessary.
•Interfaces with other testing laboratories as needed.
•Implements and manages systems related to document management and control.
•Provides ideas to drive efficiency.
•Coordinates projects and activities with other staff/departments, assures task completion.
•Has familiarity with FDA guidelines for biosimilars, USP, GLP, cGMP, Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines, ICH guidelines, and SOPs.
•Assures that laboratory personnel are following all company SOPs and safety rules.
•Assists with or manages samples for QA retains, stability, or transport to other sites.
•Assures that test batch records and deviations, OOS results, QA audits, and other paperwork are completed according to cGMPs and company SOPs.
•Excellent organizational skills needed to perform or assist with Document Management activities, such as:
o Issue books
o Organize, file, and maintain document archives to ensure documents are easily retrievable
o Process document requests
o Update and maintain document trackers and logbooks.
o Identify and implement efficiency improvements to document control process

• Performs other functions as required or assigned
• Complies with all company policies and standards

Position Requirements and Qualifications
Education:
•A bachelor's degree or a master's degree in life science (biology, chemistry, etc.).
Experience:
•Previous laboratory experience as an analyst/scientist is preferable.
•Previous experience (3 to 4 years) in cGMP pharmaceutical manufacturing environment is required.
•Working knowledge of cGMP regulation is required.
Special Skills:
•In depth understanding and technical knowledge of the analytical methods such as UV absorbance, SDS-PAGE, HPLC, IEF, and ELISA performed under QC laboratory environment, and be familiar with all basic and some complex laboratory equipment/instrumentation.
•Strong communication skills, both written and verbal.
•Must be detail oriented.
•Must be able to effectively manage time to complete assignments.
•Excellence computer skills in Microsoft Office applications.
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.
General Work Environment:
•General office environment in an open office set-up.
•Significant amount of time sitting and significant computer use.
Noise:
•Noise level accompanying an open office set-up.
Standing/Lifting:
•No special standing or lifting requirements.
Visual:
•No special requirements.
Stress:
•High paced demanding environment to meet ambitious project goals.
Travel:
•As needed to support projects
Supervisory Responsibility, if any : No
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.