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AllSTEM Connections

Quality Control Data Reviewer

Career Insights for Quality Control Analyst

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What they do

A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.

$69,465 / year median in New York

-13% projected decline

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Job Description

Quality Control Data Reviewer at AllSTEM Connections Quality Control Data Reviewer at AllSTEM Connections in GLENMONT, New York Posted in about 14 hours ago.

Type:

full-time

Job Title:
Data Reviewer II Location:
Albany NY Duration:

6+ Months Qualifications

  • BA/BS Degree in Chemistry or a relevant field and 3 years of related work experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry OR
  • MA/MS Degree in Chemistry or a relevant field and 1 year of related work experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry Preferred
  • Experience working in cGMP or GLP pharmaceutical industry environment
Responsibilities:

Responsibilities

  • Review quality control testing for compliance with internal SOPs and specifications
  • Assist in technical data review of the raw data generated for various compendial testing (such as USP/NF, EP, JP, etc.) as well as In-house and client methodologies for various client projects to ensure data accuracy and integrity
  • Collaborate with lab personnel for data review per cGMP compliance, data integrity
  • Ensure all tests are per cGMP compliance and in compliance with the company's standard operating procedures
  • Provide training to new hires as needed. Attend internal and external training on related subjects, cGMP compliance and data integrity, new techniques and procedures
  • Report back to appropriate management as to personnel performance, highlighting those areas and individuals in need of improvement as well as those exceeding expectations
  • Author, review, and/or approve Quality Management System documents, including, but not limited to, change controls, SOPs, deviations, CAPAs, etc.
  • Provide support on Raw Material release and GMP production suite commissioning activities when necessary
  • May perform QA cleaning verification and inspection activities when required
  • Other duties as assigned.