Quality Assurance Associate

Job Description

Quality Assurance Associate:
On behalf of our Biotechnology client, Procom is searching for a Quality Assurance Associate for a 1-year role. This position is an onsite position at our client’s Chapel Hill, North Carolina office.

Quality Assurance Associate - Job Description:
The Quality Assurance Associate will support QA Systems in collaboration with the Quality Assurance Manager to ensure quality processes are effectively executed at the ACT facility. This role involves managing document control systems, tracking QA progress, and supporting electronic quality management systems.

Quality Assurance Associate - Responsibilities:
• Provide direction on quality process execution for facility employees
• Manage critical document control systems, ensuring document revision and archiving
• Track QA System progress through internal auditing or metrics
• Direct and review validation work, ensuring completion against plans
• Review executed batch records, identify corrections, and resolve issues
• Investigate occurrences and deviations, identifying corrective and preventive actions
• Support batch record issuance and review
• Initiate and investigate deviations related to product manufacturing and release
• Track and trend manufacturing errors and other KPI metrics
• Support material release by inspecting incoming materials
• Act as a technical writer for policies, SOPs, and job aids
• Liaise with manufacturing to support projects
• Maintain competencies in required quality functions and EHS LMS modules
• Assist in training QA/QC members and maintaining quality electronic systems
• Participate in 5 hours of continuing education annually in relevant topics

Quality Assurance Associate - Mandatory Skills:
• Strong understanding of quality assurance processes
• Experience with document control systems
• Ability to track and analyze QA metrics
• Excellent problem-solving skills
• Strong communication and teamwork abilities
• Experience in batch record review and issuance
• Ability to investigate deviations and implement corrective actions

Quality Assurance Associate – Nice-to-Have Skills:
• Experience with MasterControl
• Background in cellular therapy
• Technical writing experience
• Familiarity with electronic quality management systems
• Experience with KPI tracking

Quality Assurance Associate – Assignment Length:
This is a 1-year contract position.

Quality Assurance Associate - Start Date:
ASAP.

Quality Assurance Associate - Assignment Location:
Chapel Hill, North Carolina, onsite.