Job Type
Full-time
Description
The Quality Assurance Associate is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, in Piscataway NJ. This employee will be responsible for supporting Kashiv BioSciences Quality Assurance management in reviewing, implementing and managing the quality system to ensure overall product and process quality. As an integral quality team member, this individual will provide assurance that all products and quality system processes in the facility are in compliance with cGMP requirements and company policies and procedures.
Requirements
Essential Duties & Responsibilities
- Provide QA support during manufacturing operations.
- Perform Raw Material, water and gas sampling, In-process and Finish Product sampling and coordinate submission of samples to QC analysis.
- Receiving of external samples and log in internal quality system.
- Assist all departments in the generation of quality system documentation; such as SOPs, deviation/investigation reports, equipment/system qualification protocols and reports, and change controls.
- Assist in document control activities (training records entries, logbook issuances, logbook archival etc.).
- Quality release of raw materials and finished products.
- Review of documentation supporting batch, warehouse, metrology, engineering and validation activities to ensure they are complete and in compliance with company policies and procedures, and cGMP requirements.
- Perform quality assurance support of manufacturing, laboratory and warehouse areas to ensure compliance with cGMP requirements and company procedures.
- Interface with cross functional departments to resolve quality issues.
- Complies with all company policies and standards.
- Performs other functions as required or assigned.
- Ensure adherence to GMP good documentation practices.
- Performs other functions as required or assigned.
- Complies with all company policies and standards.
Position Requirements and Qualification
Education
- Bachelor's degree.
- Minimum of 2 years of relevant experience in the pharmaceutical industry.
Experience
- Ability to work independently or in teams both within department and cross-functionally. Must be able to organize, plan and manage assigned tasks to bring projects to completion.
- Direct experience in manufacturing QA support (sampling, room/line clearance, cleaning verification) preferable.
- Experience in GMP document control.
- Understand the requirements and procedures related to document control and Quality Assurance.
- Ability to work with teams - good interpersonal skills.
- Strong communication skills: verbal and written.
- Organization and time management skills, detail oriented.
- Good computer skills, including in depth knowledge of Word, Excel and spread sheet software required.
- Must be able to utilize technical information appropriately to ensure documents produced are consistently clear, concise, accurate, and complete.
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