Senior QA Specialist

Company: Freyr Solutions, Client: Global Pharma company
Location: Durham
Posted on: April 24, 2025

Job Description:

Job Title:

Below, you will find a complete breakdown of everything required of potential candidates, as well as how to apply Good luck.
Senior QA Specialist - Sterile Manufacturing Equipment Qualification

Education

Bachelor's degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or a related field is required.


Equivalent qualifications with relevant industry experience will also be considered.



Required Experience

Minimum 5 years of experience in the pharmaceutical industry, with a strong background in sterile product manufacturing and testing.


At least 3 years of hands-on experience with the development, review, and approval of qualification documents such as URS, FAT, IQ, OQ, PQ for pharma/biotech manufacturing equipment and utilities.


Proven experience providing QA oversight for sterile manufacturing, process validation, and technology transfer.



Responsibilities

Provide Quality Assurance review and approval of equipment qualification documents, including pre- and post-reviews across diverse equipment (e.g., isolators, lyophilizers, fillers, incubators).


Support commissioning and qualification (C&Q) phases for a new sterile manufacturing facility, ensuring GMP compliance at every step.


Serve as QA lead for document review, including SOPs, batch records, risk assessments, change controls, and validation protocols.


Collaborate cross-functionally with operations and engineering teams to meet project timelines and regulatory expectations.


Play a critical role in preparing the site for regulatory inspections (e.g., FDA Pre-Approval Inspections), ensuring adherence to cGMP and internal Quality Systems.

Keywords: Freyr Solutions, Client: Global Pharma company, Raleigh , Senior QA Specialist, Other , Durham, North Carolina