QA Specialist

100% onsite

Schedule

Monday–Friday (must be flexible to work on weekends)

About the role

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.

Responsibilities

• Responsible for disposition of incoming production materials
• Responsible for release activities for site-manufactured drug product
• Issuance of controlled documents
• Scans and uploads batch record documents
• Strong authorship and ability to critically review investigations, interpret results, and generate technical conclusions consistent with Quality Risk Management
• Skilled in planning and organizing, decision-making, and building relationships
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management
• Able to effectively multitask
• Contributes to process improvements within scope of activity
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
• Action-oriented, customer-focused, and skilled in decision-making, building relationships, problem-solving, conflict management, planning and organizing, coaching others, and analytical thinking
• Routinely recognizes and resolves Quality issues; informs management of proposed solutions
• Seeks management guidance on complex issues
• Develops procedures
• Proposes solutions for complex issues and works with management to resolve
• Follows established procedures and performs work as assigned
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution
• Recognized Subject Matter Expert within the group
• Able to prepare written communications and communicate problems to management with clarity and accuracy

Requirements

• Relevant college or university degree required
• Minimum 4 years of relevant work experience (or equivalent combination of education and experience)
• Knowledge and experience with cGMP manufacturing, Quality, and compliance

Pay

The starting hourly compensation for this assignment is $28.83–$36.62/hr. Final individual compensation and any applicable benefits will be determined by the employer of record based on factors such as demonstrated experience, required skill, and geographic location.