Job Description

The Quality Assurance Specialist is responsible for supporting Quality Assurance programs and ensuring compliance with regulatory, quality, and manufacturing standards within a pharmaceutical or biotechnology environment. Under minimal supervision, this role will lead and support quality systems, validation activities, investigations, audits, change controls, and manufacturing quality initiatives.

The ideal candidate will possess strong technical expertise in Quality Assurance, validation, manufacturing support, and regulatory compliance, while effectively collaborating with cross-functional teams and external partners.

Key Responsibilities

• Review and approve product MPs.
• Review and approve process validation protocols and reports for manufacturing processes.
• Participate as Quality representative on incident triage teams.
• Review and approve Environmental Characterization reports.
• Support release activities for sanitary utility systems.
• Review and approve planned incidents and change controls.
• Represent Quality Assurance on New Product Introduction (NPI) teams.
• Lead investigations related to quality events, deviations, and compliance issues.
• Lead and support internal and external site audits.
• Own and maintain site quality program procedures.
• Serve as designee for the QA Manager on local CCRB activities.
• Review and evaluate risk assessments.
• Support automation activities, facilities systems, and environmental programs.
• Review and approve work orders and EMS/BMS alarms.
• Review and approve Non-Conformance investigations and CAPA records.
• Provide lot disposition decisions and authorize lots for shipment.
• Collaborate with manufacturing, validation, process development, and quality teams to ensure compliance and operational excellence.
• Interface with regulatory agencies and support inspection readiness activities.
• Support continuous improvement initiatives and quality system enhancements.

Required Skills & Competencies

• Strong knowledge of manufacturing, distribution, Quality Assurance, QAL, validation, and process development processes.
• Ability to evaluate compliance risks and support corrective actions.
• Advanced data trending, analysis, and evaluation skills.
• Strong understanding of regulatory requirements and industry standards.
• Experience supporting validation and quality system activities in regulated environments.
• Strong project management and organizational skills.
• Ability to initiate and lead cross-functional teams.
• Demonstrated leadership, negotiation, influencing, and facilitation skills.
• Ability to independently manage assignments through completion.
• Strong collaboration skills with internal and external stakeholders.
• Excellent written and verbal communication skills.
• Strong presentation and facilitation abilities.
• Proficiency in:
• Microsoft Word
• Excel
• PowerPoint
• Database and spreadsheet applications
• Ability to effectively communicate across multiple organizational levels.

Requirements

• Doctorate degree; OR

• Master’s degree with 2+ years of directly related experience; OR
• Bachelor’s degree with 4+ years of directly related experience; OR
• Associate degree with 8+ years of directly related experience; OR
• High School Diploma/GED with 10+ years of directly related experience.

Preferred Education

• Degree in Life Sciences or Engineering preferred.

Preferred Qualifications

• New Product Introduction (NPI)
• Change Control systems
• Factory Acceptance Testing (FATs)
• Validation activities
• Process Performance Qualification (PPQ)
• Pharmaceutical or biotechnology manufacturing environments
• Quality systems and regulatory compliance programs

Benefits

• Administrative Shift
• Contract position: 6 months with possible extension