Job Details

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
Location: Greenville, NC, 27834
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite

Shift: Monday To Friday From 06:00 AM To 06:00 PM

Summary

Drive quality execution across sterile operations, including manufacturing, filling, packaging, and inspection. Provide QA guidance for commercial and product development services. Support process improvement and continuous improvement initiatives. Maintain quality, compliance, and cGMP standards.

Responsibilities

• Perform daily quality assessments of facilities, personnel, documentation, and classified/non-classified areas.
• Identify errors and deficiencies and ensure compliance with procedures and cGMPs.
• Troubleshoot production issues and provide guidance on documentation corrections and aseptic techniques.
• Promote a strong quality culture among production personnel.
• Participate in RAPID event responses and provide deviation guidance.
• Escalate deviations to appropriate quality management.
• Review and approve procedures, training documents, forms, deviations, and change controls.
• Participate in Root Cause Analysis and deviation investigations as the QA representative.
• Perform quality batch record reviews.
• Identify and support continuous improvement opportunities.
• Troubleshoot process and equipment issues with production leadership.
• Maintain consistent quality presence on the production floor.

• Bachelor's degree in Technology, Engineering, Microbiology, or related field.
• 4+ years of QA, QC, Operations, or Manufacturing experience.
• Pharmaceutical industry experience, preferably aseptic/sterile manufacturing.
• Experience in regulated environments such as ISO 9001.
• Knowledge of cGMP, quality systems, deviations, change control, and investigations.
• Strong data analysis and process/equipment troubleshooting skills.
• Strong technical writing abilities.
• Leadership, teamwork, ownership, and accountability.
• Strong problem-solving and communication skills.
• Ability to work in sterile/production environments.
• CQA certification and Six Sigma training are preferred.
• Ability to stand, walk, bend, kneel, and perform aseptic/non-aseptic gowning for extended periods.
• Ability to lift and carry 10-35 lbs.