Data Quality Reviewer

Position: Data Quality Reviewer

Location: Albany, NY - Onsite

Duration: 06 months contract

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

Responsibilities:

1. Review quality control testing for compliance with internal SOPs and specifications

2. Assist in technical data review of the raw data generated for various compendial testing (such as USP/NF, EP, JP, etc.) as well as the client's In-house and client methodologies for various client projects to ensure data accuracy and integrity

3. Collaborate with lab personnel for data review per cGMP compliance, data integrity

4. Ensure all tests are per cGMP compliance and in compliance with the company’s standard operating procedures

5. Provide training to new hires as needed. Attend internal and external training on related subjects, cGMP compliance and data integrity, new techniques and procedures

6. Report back to appropriate management as to personnel performance, highlighting those areas and individuals in need of improvement as well as those exceeding expectations

7. Author, review, and/or approve Quality Management System documents, including, but not limited to, change controls, SOPs, deviations, CAPAs, etc.

8. Provide support on Raw Material release and GMP production suite commissioning activities when necessary

9. May perform QA cleaning verification and inspection activities when required

10. Other duties as assigned.