Quality Assurance Specialist – Onsite | Administrative Shift

Position Summary

We are seeking an experienced Quality Assurance Specialist to support quality systems and compliance activities within a regulated manufacturing environment. This role is responsible for providing oversight across multiple quality processes, ensuring adherence to cGMP standards, and supporting manufacturing, validation, and operational excellence initiatives.

Working with minimal supervision, the selected candidate will play a key role in quality decision-making, batch disposition, investigations, and cross-functional collaboration.

This position requires onsite presence and flexibility to support weekends and holidays as needed.

Key Responsibilities

Quality Oversight & Compliance

• Review and approve Master Production Records (MPs)
• Approve process validation protocols and reports
• Review and approve risk assessments, change controls, and CAPA records
• Provide oversight for non-conformance investigations and planned incidents
• Evaluate compliance issues and ensure timely resolution

Manufacturing & Operations Support

• Provide lot disposition and authorize product release for shipment
• Support incident triage activities
• Review and approve work orders and EMS/BMS alarms
• Oversee sanitary utility system release
• Support facilities, environmental, and automation programs

Quality Systems & Leadership

• Represent Quality Assurance on New Product Introduction (NPI) teams
• Serve as QA designee on Change Control Review Board (CCRB)
• Own and maintain site quality procedures
• Lead and support investigations and site audits
• Collaborate with cross-functional teams across Manufacturing, Engineering, and Quality

Continuous Improvement & Data Analysis

• Perform data trending and evaluation to identify improvement opportunities
• Support process development and validation activities
• Drive continuous improvement initiatives within quality systems

Preferred Qualifications

• Experience in Quality Systems and Validation
• Familiarity with systems such as:
• PAS-X / MES
• SAP, MAXIMO
• LIMS, QMTS, Veeva
• Experience working in highly regulated pharmaceutical environments
• Prior experience supporting regulatory inspections and agency interactions

Education

• PhD in a relevant field
• OR
• Master’s degree + 2 years of directly related experience
• OR
• Bachelor’s degree + 4 years of directly related experience
• OR
• Associate degree + 8 years of experience
• OR
• High School Diploma/GED + 10 years of experience

Required Skills & Competencies

• Strong knowledge of cGMP regulations and quality systems
• Experience in manufacturing, validation, and process development environments
• Proven ability to lead investigations, audits, and cross-functional initiatives
• Strong project management and organizational skills
• Excellent analytical thinking and problem-solving abilities
• Strong communication, facilitation, and presentation skills
• Ability to work independently and interact across multiple organizational levels
• Experience evaluating compliance risks and driving resolution
• Proficiency in Microsoft Office applications

Work Environment

• Location: Onsite
• Schedule: Administrative shift
• Availability: Must be flexible to support weekends and holidays as needed

Why Join

This role offers the opportunity to contribute to critical quality and compliance operations, ensuring product integrity and regulatory adherence while working in a dynamic and collaborative environment.