Masis Professional Group

Compensation

Full Description

Quality Specialist / Technical Writer * Contract with potential direct hire! Join a leading Pharmaceutical Manufacturing site in a long-term contract role as a Quality Specialist/Technical Writer. 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. • Oversee validation, qualifications, 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. Critical Skills for Success • Hands-on oversight of validation and qualification processes. • Expertise in managing customer complaints and related investigations. • Strong background in document control and procedure updates. • Ability to draft and execute qualification documents and summary reports. Education & Experience • Bachelor’s degree or higher in a scientific, quality assurance, or technical field. • 5+ years of combined experience in the pharmaceutical or related regulated industry, including compliance and project management. • Deep understanding of cGMPs, regulatory standards, and industry best practices. • Proven ability to conduct 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.