Quality Assurance Specialist

Quality Assurance Specialist

The Quality Assurance Specialist drives quality execution across sterile operations, including manufacturing, filling, packaging, inspection, and related non–batch-specific activities for both commercial and product development services. This role provides hands-on quality guidance on the production floor, ensures compliance with cGMP and site procedures, and supports practical process improvements and continuous improvement initiatives. The position operates on a 6 a.m. to 6 p.m. schedule following a 2-2-3 rotation.

Responsibilities

• Perform daily quality assessments of facilities, personnel practices, and documentation in both classified and non-classified areas to identify errors or deficiencies and ensure compliance with cGMP and site procedures.
• Interact daily with production employees to assist with troubleshooting process and equipment issues, correct and annotate documentation, and provide guidance on aseptic technique.
• Champion a strong quality culture by helping personnel understand and apply quality policies, procedures, and controls in their daily work.
• Participate in RAPID event responses and provide quality guidance during deviation events to support timely and compliant resolution.
• Advance deviation events to the appropriate operational area and quality management for further investigation and decision-making.
• Perform quality review and approval of procedures, training documents, and forms of moderate to high complexity to ensure clarity, accuracy, and compliance.
• Conduct quality review and approval of deviation records and change controls of moderate to high complexity, ensuring appropriate risk assessment and documentation.
• Serve as the quality assurance representative in Root Cause Analysis activities to support deviation investigations of moderate to high complexity.
• Perform detailed quality batch record reviews to verify completeness, accuracy, and adherence to regulatory and internal requirements.
• Identify opportunities for continuous improvement in processes and documentation, and actively participate in practical process improvement initiatives.
• Capture and analyze data related to process performance and equipment issues, collaborating with production leadership to troubleshoot and implement corrective actions.
• Support, lead, and empower peers and cross-functional teams to maintain high standards of quality and operational excellence.
• Prepare and contribute to technical writing activities, including quality-related reports, procedures, and investigation documentation.
• Maintain a consistent presence on the production floor, adhering to aseptic and non-aseptic gowning requirements while monitoring operations for quality and compliance.
• Follow all applicable safety practices, including the use of required personal protective equipment, while working in manufacturing and laboratory environments.

Essential Skills

• Bachelor's degree, preferably in technology, engineering, microbiology, or a related scientific or technical field, or an equivalent combination of education, training, and relevant work experience.
• Minimum of 4 years of experience in Quality Assurance, Quality Control, or Operations/Manufacturing.
• Previous experience in the pharmaceutical industry, with a strong preference for aseptic or sterile processes; experience in other regulated environments such as ISO 9001 may be considered.
• Demonstrated ability to capture data, analyze results, and troubleshoot process issues and equipment problems in collaboration with production leadership.
• Proven ability to troubleshoot both process and equipment issues in a regulated manufacturing environment.
• Strong sense of ownership and responsibility, with a hard-working and proactive approach to quality and operations.
• Ability to lead, support, and empower a team or peers to uphold quality standards and continuous improvement.
• Technical writing experience, including preparation or review of procedures, reports, and quality documentation.
• Knowledge and application of cGMP principles and quality assurance practices in pharmaceutical or similarly regulated environments.
• Capability to perform primary responsibilities on the production floor, requiring physical fitness for prolonged standing, walking, repetitive bending, and aseptic and non-aseptic gowning.
• Ability to stand, walk, stoop, kneel, and crouch periodically for prolonged periods, and to lift, carry, and move light to medium weights of approximately 10–35 pounds.
• Sufficient arm, hand, and finger dexterity to grasp, operate equipment, and type for extended periods, along with visual acuity to use a computer monitor, operate equipment, and read materials for prolonged periods.
• Ability to sit, reach with hands and arms, talk, and hear for prolonged periods in both office and production settings.

Additional Skills & Qualifications

• Professional certifications in quality, such as Certified Quality Auditor (CQA), are a plus.
• Training or experience in Six Sigma or other continuous improvement methodologies is advantageous.
• Experience with CAPA (Corrective and Preventive Action) processes and documentation.
• Familiarity with qualification activities in a cGMP environment.
• Strong interpersonal skills to effectively interact with cross-functional teams and production staff.
• Ability to promote and sustain a culture of quality and continuous improvement.
• Comfort working within structured quality systems, including GMP, QA, and related regulatory frameworks.

Work Environment

This role is primarily based on the production floor within sterile pharmaceutical operations and requires a consistent presence in both classified and non-classified areas. The typical schedule is 6 a.m. to 6 p.m. on a 2-2-3 rotation, which includes a mix of weekday and weekend shifts. Work involves extended periods of standing, walking, bending, and performing tasks in aseptic and non-aseptic environments. The position requires routine use of personal protective equipment such as safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, and occasionally an organic respirator. Employees work with cGMP-regulated processes and documentation, using computer systems for data entry, technical writing, and batch record review. The environment emphasizes safety, cleanliness, and adherence to strict quality and regulatory standards, with a culture focused on collaboration, continuous improvement, and operational excellence.

Job Type & Location

This is a Contract position based out of Greenville, NC.

Pay and Benefits

The pay range for this position is $15.00 - $27.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Greenville,NC.

Application Deadline

This position is anticipated to close on Aug 31, 2026.