QA Specialist

Work Schedule

100% onsite. Regular schedule is Monday‑Friday, with flexibility to work on weekends as needed.

Position Summary

The Specialist is responsible for quality and disposition activities in accordance with client policies, standards, procedures and Global cGMP. Functional responsibilities include performing incoming material release and product release, ensuring accurate and timely maintenance, and performing document issuance for manufacturing.

Duties/Responsibilities

• Disposition of incoming production materials.
• Release activities for site‑manufactured drug product.
• Issuance of controlled documents.
• Scanning and uploading batch record documents.
• Authorship and critical review of investigations, interpretation of results, and generation of technical conclusions consistent with Quality Risk Management.
• Planning and organizing, decision‑making, and building relationships.
• Application of quality processes including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Effective multitasking.
• Contribution to process improvements within scope of activity.

Qualifications

• Knowledge and experience with cGMP manufacturing, quality, and compliance.
• Ability to direct quality initiatives that achieve continuous improvement and enhance site quality system efficiencies.
• Action‑oriented, customer‑focused, skilled in decision‑making, relationship building, problem solving, conflict management, planning and organizing, coaching, and analytical thinking.
• Routine recognition and resolution of quality issues; informs management of proposed solutions and seeks guidance on complex issues.
• Development of procedures and proposal of solutions for complex issues.
• Adherence to established procedures and assigned work.
• Intermediate to advanced ability to interpret results and articulate recommendations.
• Recognized subject‑matter expert within the group.
• Strong written communication skills; ability to convey problems to management with clarity and accuracy.

Education / Experience / License / Certification

• Relevant college or university degree required.
• Minimum 4 years of relevant work experience, or an equivalent combination of education and experience.

Compensation

The starting hourly compensation for this assignment is within the range of $28.83‑$36.62 per hour. Final individual compensation and any applicable benefits will be determined by the employer of record and may vary based on experience, required skills, and geographic location.