Quality Assurance (QA) Specialist I, II, & III

Quality Assurance Specialist

Creating a Healthier World through Accessible Biologics:

Kashiv Bio Sciences, LLC is a fully integrated biopharmaceutical company. Kashiv Bio Sciences, LLC, in the United States, and its subsidiary, Kashiv Bio Sciences Private Limited, in India (together "Kashiv Bio Sciences") operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

The Quality Assurance Specialist is a regular employee in a full-time exempt position at Kashiv Bio Sciences, LLC, in Piscataway, NJ. This employee will be responsible for supporting Kashiv Bio Sciences 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.

Assists in the direction and training of other quality team members.

Position involves reviewing and assembling batch documentation, issuing and tracking controlled documents, reviewing raw material documentation and releasing material, reviewing deviations, CAPAs, chance controls, validation/qualification, facility preventive maintenance, and calibration records. Position also involves the completion of manufacturing clearance activities to ensure requirements are met prior to and upon completion of manufacturing activities, and to serve as the witness for critical steps in manufacturing records and quality control documents.

Essential Duties & Responsibilities:

• Manage a broad spectrum of projects to support the needs of Quality Management.
• Issue, assembly, and review of documentation supporting batch, laboratory, warehouse, metrology, engineering, and validation activities, to ensure complete and in compliance with company policies and procedures and cGMP requirements. Quality system documentation to include SOPs, deviation/investigation reports, equipment/system qualification protocols and reports, change controls, as well as document control activities (training records entries, logbook issuances, logbook archival, etc.)
• Interface with cross-functional departments. Perform quality assurance walk-through audits of manufacturing, laboratory, and warehouse areas to ensure compliance with CGMPs and company procedures.
• Quality support of environmental/quality monitoring and release of controlled systems and environments. Support includes data review for release and support of investigation activities.
• Assist and provide input as part of a project team to resolve quality and manufacturing issues and identify and implement corrective and preventive actions in a timely manner.
• Perform Raw Material, water, and gas sampling, In-process and Finish Product sampling, and coordinate submission of samples to QC analysis.
• Receiving external samples and logging into the internal quality system
• Quality release of raw materials and finished products.
• Provide backup for other Quality Assurance Specialist responsibilities. Perform other duties and responsibilities as delegated by Quality Management.
• Ensure adherence to GMP good documentation practices
• Complies with all company policies and standards

Requirements

Position Requirements and Qualifications

Minimum Qualifications:

• A 4-year Bachelor's degree, preferably in a science or engineering discipline

Experience:

• Previous experience for QA I (0 to 2 years or more), QA II (2 to 5 years or more), and QA III (5 plus years) in a cGMP biologics/biosimilars manufacturing laboratory environment is required.
• Working knowledge of cGMP regulations (21 CFR
  210/211/820) is desired.
• Working knowledge of Deviation, CAPA, Change Control, and Validation/Qualification (IQ/OQ/PQ) is desired.
• Certification from professional organizations such as ASQ and ISPE is desired but not required.

Preferred Qualifications:

SPECIALIZED KNOWLEDGE AND SKILLS:

• Good communication skills, both written…