Quality Assurance Specialist

Job Summary The QA Specialist I – Manufacturing Quality Assurance (MQA) is responsible for providing on-the-floor support to manufacturing, filling, and packaging operations to ensure compliance with cGMP, SOPs, and applicable regulatory requirements. This entry-level role focuses on performing in-process quality checks, assisting in batch record review, and supporting deviation documentation under the guidance of senior QA staff. The Specialist I helps maintain product quality, compliance, and patient safety by executing defined QA responsibilities and building technical expertise in pharmaceutical quality systems.

Job Summary The QA Specialist I – Manufacturing Quality Assurance (MQA) is responsible for providing on-the-floor support to manufacturing, filling, and packaging operations to ensure compliance with cGMP, SOPs, and applicable regulatory requirements. This entry-level role focuses on performing in-process quality checks, assisting in batch record review, and supporting deviation documentation under the guidance of senior QA staff. The Specialist I helps maintain product quality, compliance, and patient safety by executing defined QA responsibilities and building technical expertise in pharmaceutical quality systems.

Reporting to: Quality Assurance Supervisor

Location: Johnson City, TN Manufacturing Plant

Schedule: Mon-Fri 7:00AM - 4:30PM

Responsibilities/Essential Duties

• Perform quality checks during manufacturing, filling, and packaging activities, including weight checks, seal integrity checks, line clearance verification, cleaning verification, and label reconciliation.
• Document inspection activities in accordance with Good Documentation Practices (GDP) and company procedures.
• Assist in the review of executed batch records for completeness and accuracy.
• Support QA oversight of equipment set-up and clearance activities under supervision.
• Participate in deviation documentation and investigations under the guidance of senior QA staff.
• Aid in the preparation and revision of SOPs and controlled documents.
• Perform other quality-related tasks as assigned by QA Management.
• Follow established procedures to ensure compliance with 21 CFR Parts 210/211, ICH guidelines, and company Quality Management System (QMS) requirements.
• Uphold GDP and data integrity standards during all inspection and documentation activities.
• Escalate potential compliance issues to senior QA staff in a timely manner.
• Support regulatory inspections and customer audits by providing accurate information as requested.
• Demonstrate proficiency in inspection methodologies, measurement tools, and acceptance sampling standards (e.g., ANSI/ASQ Z1.4).
• Gain working knowledge of cGMP manufacturing and packaging operations.
• Learn and apply basic root cause analysis and problem-solving tools under the direction of senior QA personnel.
• Build proficiency in quality oversight practices and regulatory expectations through on-the-job training.
• Collaborate with operations staff to reinforce compliance and quality standards on the production floor.
• Participate in quality training sessions to support professional growth and readiness for Level II responsibilities.

Basic Qualifications

• High School Diploma or equivalent required;
  Associate degree in a scientific or technical discipline preferred.
• Minimum 0–2 years of experience in Quality Assurance, Manufacturing, or a regulated industry (pharmaceutical/biotechnology preferred)
• Basic understanding of cGMP and regulatory requirements for pharmaceutical production.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).
• Strong attention to detail, communication, and organizational skills.
• Ability to follow procedures, take direction, and work collaboratively in a team environment

Company…