Quality Assurance Specialist - Sterile Manufacturing

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands.

Position: Quality Assurance Specialist Sterile Manufacturing

Location: Greenville NC 27834

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift: First Shift - 06:00 AM to 06:00 PM - Rotational shift in 2-2-3 pattern

Summary:

Responsible for driving quality execution across sterile operations, including manufacturing, filling, packaging, inspection, and associated non-batch-specific activities. Provides Quality Assurance guidance for commercial and product development services. Supports practical process improvements and continuous improvement initiatives. Ensures compliance with site procedures, cGMPs, and quality standards.

Responsibilities

• Perform daily quality assessments of facilities, personnel, and documentation in classified and non-classified areas.
• Identify errors and deficiencies and ensure quality and cGMP compliance.
• Provide daily guidance to employees on troubleshooting, documentation corrections, and aseptic techniques.
• Promote a strong quality culture by supporting personnel in understanding and applying policies and controls.
• Participate in RAPID event response and provide Quality guidance for deviation events.
• Escalate deviation events to appropriate areas and Quality Management.
• Review and approve procedures, training documents, and forms of moderate to high complexity.
• Review and approve deviations and change controls of moderate to high complexity.
• Participate as the Quality Assurance representative in Root Cause Analysis and deviation investigations.
• Perform quality review of batch records.
• Identify continuous improvement opportunities and participate in process improvement initiatives.
• Collaborate with production leadership to troubleshoot process and equipment issues.
• Capture and analyze data to support troubleshooting and quality decisions.
• Maintain consistent production-floor presence and perform required aseptic and non-aseptic gowning.

Required Skills

• Bachelor's degree required, preferably in Technology, Engineering, Microbiology, or a related field.
• Minimum 4 years of relevant experience in Quality Assurance, Quality Control, Operations, or Manufacturing.
• Pharmaceutical industry experience strongly preferred, particularly aseptic or sterile manufacturing.
• Experience in other regulated environments, such as ISO 9001, may be considered.
• Strong knowledge of cGMP, quality systems, deviation management, change control, and Root Cause Analysis.
• Experience with batch record review, aseptic techniques, process troubleshooting, and equipment troubleshooting.
• Ability to capture and analyze data and identify process issues.
• Strong technical writing skills.
• Ability to lead, support, and empower teams and peers.
• Strong ownership, accountability, communication, and problem-solving skills.
• CQA certification and Six Sigma training/certification are a plus.
• Ability to stand, walk, bend, kneel, and crouch for prolonged periods.
• Ability to lift and move 10 35 pounds and work on the production floor while wearing required PPE.

TekWissen Group is an equal opportunity employer supporting workforce diversity.