Quality Control Data Reviewer

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.