Job Description
Quality Specialist * No C2C or sponsorship available for this job.
$65-75k
Potential Contract-to-Direct for the right person!
Join a fast growing Pharmaceutical Manufacturing site in a long-term contract role as a Quality Specialist. In this position, you’ll play a vital role in driving compliance, elevating operational standards, and supporting the production of critical care products that impact patients worldwide!
Job Summary: Strive to proactively drive the Quality culture at the site and promote cGMP activities. This person will work hands-on with the responsibility of ensuring compliance, improving practices, and qualifying/validating new processes with company strategic goals as a guide. The role may also serve as a liaison between the Operations group and the QA/QC department for day-to-day activities, capital projects, and process improvements.
Essential Duties & Responsibilities
- Provide documentation and compliance support to meet Global Regulatory Requirements for licensed products.
- Partner with cross-functional departments to address GMP requirements in validation, investigations, complaints, procedure updates, and change control.
- Manage multiple priorities while providing leadership, guidance, and feedback to team members.
- Drive packaging OEE (Overall Equipment Effectiveness) initiatives.
- Support qualifications, deviations, customer complaints , investigations, and systems compliance.
- Maintain oversight of the PAS-X system and ensure 24/7 audit readiness.
- Support regulatory audits with thorough preparation and follow-through.
- Lead document control activities to ensure accuracy, consistency, and compliance.
Education & Experience
- Bachelor’s degree or higher in a scientific, quality assurance, or technical field.
- 1+ years of experience in the pharmaceutical or related regulated industry .
- Knowledge/understanding of cGMPs, regulatory standards, and industry best practices.
- Ability to assist in investigations, interpret regulations, and make sound quality decisions.
- Exceptional verbal and written communication skills with the ability to collaborate across departments and leadership levels.
- Proficiency in Microsoft Outlook, Excel, Word, and other web-based systems.
- Strong problem-solving skills with the ability to lead projects and deliver timely results.
Job Tags
Long term contract, Contract work, Worldwide,