Chicago, Illinois, United States · On-site
$60k–$65k/yr
Description Company Overview Creating a Healthier World through Accessible Biologics: Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidi…
Skills: Document Control, Quality Assurance, cGMP Compliance, Electronic Document Management Systems, Archiving
Chicago, Illinois, United States · On-site
Description Creating a Healthier World through Accessible Biologics: Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSc…
Skills: cGMP Regulations, Quality Assurance, Inspection and Sampling, Batch Record Review, Technical Report Writing
Piscataway, New Jersey, United States · On-site
$70k–$95k/yr
Description Company Overview Creating a Healthier World through Accessible Biologics: Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC, in the United States, and its subsid…
Skills: HPLC, SDS-PAGE, Cell-based Bioassays, Capillary Electrophoresis, ELISA
Chicago, Illinois, United States · On-site
$65k–$70k/yr
Description Position Summary The Manufacturing Support Specialist is a full-time exempt role supporting GMP manufacturing operations at Kashiv BioSciences, LLC, Chicago, IL. The Manufacturing Support Specialist provides …
Skills: Technical Writing, GMP Compliance, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Chicago, Illinois, United States · On-site
$26/hr–$30/hr
Description Creating a Healthier World through Accessible Biologics: Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSc…
Skills: Aseptic Techniques, Cleanroom Manufacturing, Upstream Fermentation, Downstream Purification, Chromatography
Chicago, Illinois, United States · On-site
$26/hr–$30/hr
Description Creating a Healthier World through Accessible Biologics: Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSc…
Skills: Aseptic Techniques, Cleanroom Manufacturing, Upstream Fermentation, Downstream Purification, Chromatography
Piscataway, New Jersey, United States · On-site
$30/hr–$38/hr
Description Creating a Healthier World through Accessible Biologics: Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSc…
Skills: Downstream Processing, cGMP, Chromatography, TFF Systems, Column Packing
Piscataway, New Jersey, United States · On-site
$30/hr–$38/hr
Description Company Overview Creating a Healthier World through Accessible Biologics: Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidi…
Skills: Mammalian Cell Culture, cGMP, Bioreactor Operations, Aseptic Processing, Depth Filtration
Piscataway, New Jersey, United States · On-site
$70k–$100k/yr
Description Creating a Healthier World through Accessible Biologics: Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSc…
Skills: QMS, Deviation Writing, Change Control, CAPA, Batch Record Review
Piscataway, New Jersey, United States · On-site
Description Downstream Manufacturing Scientist (Piscataway, NJ): Perform downstream process at multiple scales in a cGMP environment, column packing, process troubleshooting and data analysis; provide technical direction…
Skills: Process Development, cGMP Manufacturing, MSAT, Bacterial Cell Culture, Mammalian Cell Culture
Piscataway, New Jersey, United States · On-site
Description QC Analyst III (Piscataway, NJ): Be primarily responsible for the execution and review of HPLC/UPLC assays & impurity testing along with Bio-assays for release & stability purposes in a GMP-complaint Quality …
Skills: HPLC, UPLC, Impurity Testing, Bio-assays, GMP Compliance
Piscataway, New Jersey, United States · On-site
Description Position Summary The Data Maintenance & Reporting Coordinator will support Manufacturing Science & Technology (MSAT) operations by ensuring the integrity, accuracy, and timely availability of manufacturing, q…
Skills: Data Validation, Data Reconciliation, Reporting, Dashboard Development, GMP Compliance
Piscataway, New Jersey, United States · On-site
$70k–$95k/yr
Description Position Summary Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC, in the United States, and its subsidiary, Kashiv BioSciences Private Limited, in India (toget…
Skills: cGMP Compliance, Quality Assurance, Document Control, CAPA, Deviation Investigation
Piscataway, New Jersey, United States · On-site
$70k–$95k/yr
Description Position Summary Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC, in the United States, and its subsidiary, Kashiv BioSciences Private Limited, in India (toget…
Skills: Microbiological Testing, Organism Identification, Aseptic Process Review, Environmental Monitoring, Sterility Testing
Chicago, Illinois, United States · On-site
Description Position Summary The Quality Control Analyst II will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial biosimilar products in cGMP-compliant labora…
Skills: HPLC, SDS-PAGE, Cell-based Bioassays, Capillary Electrophoresis, ELISA
Piscataway, New Jersey, United States · On-site
$25/hr–$45/hr
Description Position Summary This IT Systems Support position (On-site) in Information and Technology Services is a Temporary/Non-Exempt position (6 months to Hire) at Kashiv BioSciences, LLC, in Piscataway, NJ (Primary …
Skills: Tier 1 Technical Support, Active Directory, Azure AD, Office 365, Network Diagnostics
Chicago, Illinois, United States • On-site
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Responsible for the review, issuance, control, and archival of controlled documents including batch records and test methods. Additionally supports the maintenance of employee training files and curricula to ensure regulatory compliance.
Requires an associate or bachelor's degree in life science or computer science, or 1-2 years of experience in document control, preferably within a cGMP-regulated industry. Experience with electronic document management systems and MasterControl certification are preferred.
Description
Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSciences Private Limited in India (together “Kashiv BioSciences”), 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 Documentation Specialist I is a regular employee in a full-time position at Kashiv BioSciences, LLC, in Chicago, IL. The employee is responsible for assisting with the review, issuance, control, formatting, reconciliation, and archival of procedures, forms, test methods, and related controlled documents throughout the organization. The Documentation Specialist I will also support maintenance of employee training files and training curricula to help ensure employees remain current in assigned training.
Essential Duties & Responsibilities
Requirements
Education:
Certifications, Licenses, etc.:
This position is onsite 5 days a week from 9 AM EST to 5:30 PM EST
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.
Supervisory Responsibility, if any: No
L10 minutes away from Downtown Chicagont 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.
Accelerating Healthcare through Affordable & Equitable Biologics
Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together “Kashiv BioSciences”) 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.
Offices: 995 US Highway 202/206, Bridgewater, New Jersey 08807, US · 20 New England Ave, Piscataway, New Jersey 08854, US · 3445 S Dearborn St, Chicago, Illinois 60616, US · Sardar Patel Ring Road, Opp. Applewoods Township, Ahmedabad, Gujarat 382210, IN · SH144, Sanand, Gujarat 382110, IN
Accelerating Healthcare through Affordable & Equitable Biologics
Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together “Kashiv BioSciences”) 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.
Offices: 995 US Highway 202/206, Bridgewater, New Jersey 08807, US · 20 New England Ave, Piscataway, New Jersey 08854, US · 3445 S Dearborn St, Chicago, Illinois 60616, US · Sardar Patel Ring Road, Opp. Applewoods Township, Ahmedabad, Gujarat 382210, IN · SH144, Sanand, Gujarat 382110, IN
