QA Technical Services Specialist

QA Technical Services Specialist (2nd Shift)

WHO?:

This role is a great opportunity to work with Quality Control (QC) personnel but within the realm of Quality Assurance. The candidate will have the opportunity to learn about the equipment used to perform testing as well as the different methods for performing each test. The ideal candidate will be able to communicate with the other data reviewers to ensure adherence to quality standards.

This position will support primarily second shift (3:00-11:30pm).

WHAT?:

The role responsibilities are, but are not limited to:

• Perform laboratory data review processes for incoming materials, in-process, finished product, and stability testing from QC Chemistry, Microbiology, IQC and Method Transfer.
• In coordination with QA and QC management, use knowledge of quality principles, cGMPs, and regulatory standards to maintain a state of constant inspection-readiness in the QC laboratories.
• Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, etc.) to ensure data integrity for all Quality Assurance and Quality Control site policies, procedures, and testing records.
• Use technical skills and applied statistics to analyze and identify sources of variability and error in QC processes.

YOU

Ideally, candidates will have a Bachelor’s degree in Science (or 5 years’ relevant experience). They will also have:

• 4+ years’ experience of GMP biopharma industry experience, with at least 1 year experience with isolator-based aseptic manufacturing environments required.
• Experience as a technical data reviewer in a GMP regulated industry.
• High level of understanding and oversight of Quality Control testing processes for aseptic manufacturing.

Interested? Send us your resume at ***email_hidden*** or you can find more information on our website.

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.