Quality Specialist /Technical Writer

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.