Quality Specialist I, Documentation Systems

About the role

Knoa Pharma is a public health-driven pharmaceutical company dedicated to addressing the opioid crisis. Our focus is on expanding access to lifesaving overdose reversal medicines and affordable treatments for opioid use disorder. Owned by a not-for-profit foundation, everything we do is centered on improving public health, saving lives, supporting recovery, and bringing forward medicines that make a meaningful difference.

The Quality Assurance (QA) Specialist I, Documentation Systems encompasses several Quality Systems. The position conducts technical quality compliance related activities in accordance with GxP regulations and internal Standard Operating Procedures.

Responsibilities

• Ensures that documentation is maintained/archived in accordance with internal procedures and regulatory requirements (i.e., GxP, etc.).
• Compiles global regulatory submission certifications and documentation as required by business partners for ex-US submissions.
• Provides support with product and process investigations and data analysis, as requested by Quality management.
• Utilizes knowledge of regulatory requirements to identify, describe and communicate issues and participates in problem resolution and corrections.
• Issues documents, including but not limited to Master Batch Records, Write-up Pages, Logbooks and Lab Notebooks.
• Participates in resolving deviations associated with the Documentation Systems group.
• Participates in the management of the document period review process.
• Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments.
• Authors, revises, and approves job related controlled documents.
• Processes documents and requests using applicable quality systems.
• Maintains current knowledge base within relevant technical discipline of FDA regulations and awareness of the necessity and impact of compliance of the business.
• Communicates and participates in identified improvements as well as mitigation of potential gaps.
• Supports regulatory inspections, as necessary.
• Performs other related assignments and duties as required.

Requirements

• Bachelor’s degree required and 4 years minimum relevant experience in supporting and maintaining quality systems, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS preferred) with 2 years minimum relevant experience.

Skills

• Demonstrated advanced knowledge and proficiency within the primary discipline, with the ability to apply technical expertise to achieve departmental and organizational objectives.
• Thorough understanding of Quality Systems, processes, and tools, with the ability to ensure compliance and support continuous improvement initiatives.
• Working knowledge of GxP regulations across related disciplines and an understanding of their impact on cross-functional operations and compliance requirements.
• Ability to effectively adapt to shifting priorities, assess changing business needs, and proactively identify opportunities arising from evolving circumstances.
• Strong problem-solving and communication skills, with the ability to identify challenges, assess potential impacts, communicate issues in a timely manner, and contribute to effective resolution strategies.
• Ability to provide guidance and support to personnel across multiple departments regarding document issuance, document control practices, records management, archival processes, and the use of Veeva Electronic Document Management System (EDMS).

Physical and Environmental Requirements

This position is performed in an office or professional work environment. Essential functions include the ability to sit for extended periods, use a computer, and other office equipment, communicate effectively, and occasionally move within the work area.

Schedule

Ability to work a 10.5-hour per day, 4-day work week (Monday–Thursday), 40 hours per week with additional hours as needed to meet business objectives and job responsibilities.

Supervisory Responsibilities

Reports to the Associate Director, Quality Documentation Systems and operates as an individual contributor with no direct supervisory responsibility. Independently prioritizes and manages workload to meet departmental objectives, timelines, and compliance requirements. Performs routine and non-routine activities within the functional area with a high degree of autonomy, exercising sound judgment while seeking guidance as needed.

• Plans, executes, documents, and communicates Quality Assurance and compliance-related activities, providing timely updates and recommendations to management.
• Collaborates effectively with cross-functional departments to support business, quality, and compliance objectives.
• Serves as a liaison with internal stakeholders and may interact with external regulatory agencies, auditors, and business partners as required.
• Demonstrates accountability for assigned responsibilities, ensuring work is completed accurately, efficiently, and in accordance with applicable procedures and regulatory requirements.