Senior QA Specialist Position Available In Durham, North Carolina
Tallo's Job Summary: The Senior QA Specialist - Sterile Manufacturing Equipment requires a Bachelor's degree in a relevant field and a minimum of 5 years of pharmaceutical industry experience. Responsibilities include reviewing and approving equipment qualification documents, supporting commissioning and qualification phases for new facilities, and preparing sites for regulatory inspections. The role involves collaborating with cross-functional teams to ensure GMP compliance and meet project timelines.
Job Description
Job Description:
Job Title:
Below, you will find a complete breakdown of everything required ofpotential candidates, as well as how to apply Good luck. Senior QA Specialist – Sterile Manufacturing EquipmentQualification Education Bachelor’s degree in Biology, Microbiology, Pharmacy, Chemistry,Chemical Engineering, or a related field is required. Equivalent qualifications with relevant industry experience willalso be considered. Required Experience Minimum 5 years of experience in the pharmaceutical industry, witha strong background in sterile product manufacturing andtesting. 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 andutilities. Proven experience providing QA oversight for sterile manufacturing,process validation, and technology transfer. Responsibilities Provide Quality Assurance review and approval of equipmentqualification documents, including pre- and post-reviews acrossdiverse equipment (e.g., isolators, lyophilizers, fillers,incubators). Support commissioning and qualification (C&Q) phases for a newsterile manufacturing facility, ensuring GMP compliance at everystep. Serve as QA lead for document review, including SOPs, batchrecords, risk assessments, change controls, and validationprotocols. Collaborate cross-functionally with operations and engineeringteams to meet project timelines and regulatory expectations. Play a critical role in preparing the site for regulatoryinspections (e.g., FDA Pre-Approval Inspections), ensuringadherence to cGMP and internal Quality Systems.
