QA Lead

QA Lead - Biotechnology - North Carolina - 6-Month Contract

Our client is a leader in helping address some of the world’s biggest science, health, and environmental challenges. The company work together to accelerate research, solve complex analytical challenges, improve patient diagnostics, drive laboratory productivity and produce life-saving treatments for patients.


Responsibilities:

• Generate and maintain the contamination control strategy.
• Promote understanding of and compliance with SA related regulations such as EU Annex 1 & the FDA’s aseptic processing guide.
• Conduct regular GEMBA style assessments of the aseptic process on site to assess compliance, identify improvements and provide real time coaching to aseptic staff.
• Define, oversee and where necessary improve the EM & APS programs.
• Ensure that suitable aseptic comportment/training/oversight programs are in place and effective. The programs should cover aseptic operators and the first line managers/quality staff charged with overseeing aseptic manufacturing and must be appropriate to the SA related tasks each person conducts.
• Ensure that all sterilization processes are being managed compliantly.
• Conduct risk assessments and improvement programs to ensure that SA practices stay aligned with current and future regulatory expectations.
• Lead major investigations into issues impacting SA (i.e. Adverse EM trends, media fill failures)
• Review & approve any major/critical deviation and any change proposals with SA impact.
• Stay up to date with best practice and actively share that knowledge.
• Act as SA SME for the above with regulators / clients (i.e. key part of major audits)
• Act as SA SME for new product introduction and for applicable capital projects (i.e. new lines/processes)

Requirements:

• Substantial experience, minimum 7-10 years’ working in or directly supporting manufacturing within a sterile pharmaceutical manufacturing site. This position requires deep understanding of sterile product manufacture and good aseptic practices. This knowledge needs to be combined with quality risk management principles.
• Strong working knowledge of the principles and guidelines for GMP as set out in the Eudralex Volume 4, U.S. 21CFR part / and able to operate as a subject matter expert on regulations pertaining to aseptic manufacturing such as EU Annex 1 and the FDA aseptic processing guide.
• Is not afraid to make decisions. Holds self and others accountable in achieving goals.
• Strong leadership skills with good collaboration, communication, and problem-solving skills.
• Excellent written and verbal communication skills to internal and external stakeholders
• Wants to learn and have a natural curiosity to understand systems and processes.
• Ability to work in a fast paced, matrix environment essential.
• Capable of working to deadlines and prioritizing multiple tasks.

If this role is of interest to you, please apply now!

North Carolina