Quality Assurance Specialist

Location: Greenville, NC
Pay Rate: $27.00 per hour
Schedule: 6:00 PM–6:00 AM
Shift: 12-hour shifts on a 2-2-3 rotation
Work Setting: Fully on-site
Interview: In-person

Position Summary

We are seeking an experienced Quality Assurance Specialist to support sterile pharmaceutical manufacturing operations. This position will provide quality oversight across manufacturing, filling, packaging, inspection, and related production activities.

The successful candidate will serve as a quality resource on the production floor, helping teams maintain compliance with cGMP requirements, troubleshoot quality concerns, support investigations, and identify opportunities for process improvement.

Key Responsibilities

• Perform daily quality assessments of facilities, personnel, documentation, and classified and non-classified production areas.

• Identify errors, deficiencies, and compliance concerns and ensure appropriate corrective actions are taken.

• Provide day-to-day quality guidance to manufacturing personnel.

• Assist employees with documentation corrections, troubleshooting, and proper aseptic techniques.

• Promote and reinforce a strong quality culture across production teams.

• Participate in rapid response activities and provide quality guidance during deviation events.

• Escalate deviations and quality concerns to appropriate departments and quality management.

• Review and approve procedures, training documents, and forms of moderate to high complexity.

• Review and approve deviations and change controls.

• Participate in root cause analysis and support investigations of complex deviations.

• Perform quality review of batch production records.

• Identify opportunities for continuous improvement and participate in process improvement initiatives.

• Partner with production leadership to troubleshoot process and equipment issues.

• Maintain a consistent presence on the manufacturing floor to support quality execution.

Required Qualifications

• Bachelor's degree in technology, engineering, microbiology, or a related scientific/technical discipline preferred.

• Equivalent combinations of education, training, and relevant experience may be considered.

• Minimum 4 years of relevant experience in Quality Assurance, Quality Control, Operations, or Manufacturing.

• Previous experience in the pharmaceutical industry strongly preferred.

• Experience with aseptic or sterile manufacturing processes is highly preferred.

• Experience in other regulated environments, such as ISO 9001, may also be considered.

• Strong problem-solving and troubleshooting abilities.

• Ability to collect and analyze data and identify process or equipment issues.

• Strong technical writing and documentation skills.

• Demonstrated ownership, accountability, and attention to detail.

• Ability to lead, support, and collaborate effectively with peers and cross-functional teams.

• Professional certifications such as CQA or training in Six Sigma are a plus.

Physical Requirements

This position requires frequent presence on the manufacturing floor and the ability to:

• Stand and walk for extended periods.

• Bend, stoop, kneel, and crouch as needed.

• Lift, carry, and move materials weighing approximately 10–35 pounds.

• Perform repetitive hand and arm movements.

• Use computers, laboratory equipment, and other production-related systems.

• Complete aseptic and non-aseptic gowning procedures.

• Maintain appropriate visual, physical, and communication abilities necessary to safely perform job duties.

PPE & Dress Requirements

Required PPE may include:

• Safety glasses

• Safety shoes

• Lab coat

• Nitrile or similar protective gloves

• Safety apron

• Organic respirator when required

Schedule

6:00 PM–6:00 AM
12-hour shifts
2-2-3 rotating schedule
Includes a 40-minute paid lunch.

Work Environment

This is a full-time, fully on-site position within a sterile pharmaceutical manufacturing environment. The role requires consistent production-floor presence and close interaction with manufacturing and quality personnel.

Interview Process

In-person interview

Compensation

$27.00 per hour

Pay Details: $27.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.