Pharmaceutical Quality Specialist

The Pharmaceutical Quality Specialist is responsible for overseeing and managing documentation and processes essential for qualification activities related to pharmaceutical manufacturing and quality processes. This role ensures compliance with regulatory standards (e.g., FDA, EMA, and cGMP) and company policies, ensuring that all quality system documentation and processes meet the highest quality standards. The Pharmaceutical Quality Specialist plays a key role in maintaining product integrity, patient safety, and overall compliance within the organization.

Job Duties & Responsibilities

Quality Operations: 

• Author, review and/or approve procedures, reports, batch records and other necessary documents to support ongoing manufacturing processes that follow regulatory standards.
• Responsible for Quality Operations oversight including real-time batch record review, response to deviations and implementation of corrective actions.
• Provide Quality review and support for calibration and maintenance programs and ensure they are run following GMP regulation.
• Participate in or lead quality risk analysis.
• Responsible for performing quality-based training of operations team members.

Documentation and Compliance:

• Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control and management escalation.
• Ensure the correct and prompt creation, review, and maintenance of quality system documents and records.
• Support internal and external audits, inspections, and regulatory submissions.

Validation Management:

• Ensure that all validation activities are conducted in compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality standards.
• Lead and manage the validation documentation lifecycle for equipment, processes, facilities, and computer systems in the pharmaceutical environment.
• Review and approve validation protocols (IQ, OQ, PQ) and reports.

Process Improvement:

• Collaborate with cross-functional teams, including Manufacturing, Engineering, and Regulatory Affairs, to identify opportunities for process improvements and enhancements.
• Support continuous improvement initiatives and implement best practices for quality processes.

Stakeholder Collaboration:

• Act as the subject matter expert (SME) for validation and documentation activities during regulatory inspections and internal/external audits.

The salary range for this position is $60,000 to $70,000, with the final offer determined based on factors such as the candidate's experience, qualifications, skills, and education. In addition to a competitive base salary, this position is eligible to participate in Phlow's bonus and stock option programs. Phlow also offers a comprehensive benefits package that includes medical, life, and disability insurance; retirement savings plans; paid time off and company holidays; and education-related benefits. Many of these programs are fully funded or significantly subsidized by the company, reflecting our commitment to supporting the health, well-being, and professional development of our employees.