Quality Specialist I, Documentation Systems

Knoa Pharma; Wilson (NC); On-site; USD 65,000 - 85,000; Full time

Job summary

Knoa Pharma is seeking a QA Specialist I, Documentation Systems to support quality systems and regulatory compliance. The role focuses on coordinating global submission documentation, performing routine revisions, issuing and archiving documents, and maintaining FDA/GxP alignment.

Ideal candidates have a Bachelor’s degree with 4+ years in pharmaceutical quality systems, and familiarity with Veeva EDMS and regulatory expectations.

Qualifications

• Bachelor's degree in a relevant field and 4+ years' experience supporting quality systems.
• Experience with GMP/GxP documentation and compliant record-keeping.
• Familiarity with FDA regulations and quality systems tooling such as EDMS.

Responsibilities

• Maintains documentation per internal procedures and regulatory requirements.
• Supports global regulatory submission documentation as required by partners.
• Assists product/process investigations and data analyses for quality management.
• Issues and manages documents, including controlled records and logs.
• Participates in deviation resolution and the document period review process.
• Coordinates with QA and related departments to ensure compliance.
• Communicates improvements and helps close regulatory gaps.
• Supports regulatory inspections when necessary.

Skills

Quality Systems

GxP regulations

Documentation control

Communication

Problem solving

Education

Bachelor's degree

MS preferred

Tools

Veeva EDMS

Job description

Join Knoa Pharma
Knoa Pharma is a public health-driven pharmaceutical company dedicated to addressing the opioid crisis. Our focus is onexpanding access to lifesaving overdose reversal medicines and affordable treatments for opioid use disorder.Ownedbya not-for-profit foundation,everything we do is centeredonimproving public health,saving lives,supportingrecovery,and bringing forward medicines that make a meaningful difference.

Join Knoa Pharma
Knoa Pharma is a public health-driven pharmaceutical company dedicated to addressing the opioid crisis. Our focus is onexpanding access to lifesaving overdose reversal medicines and affordable treatments for opioid use disorder.Ownedbya not-for-profit foundation,everything we do is centeredonimproving public health,saving lives,supportingrecovery,and bringing forward medicines that make a meaningful difference.
Knoa Pharma has a robust generics and branded portfolio of medicines in development to address unmet medical needs, and it supports public health initiatives to address the opioid crisis. Its public health-minded purpose enables the company to expand access to lifesaving opioid overdose reversal medicines and affordable treatments for opioid use disorder - at no profit.

Position Summary

The Quality Assurance (QA) Specialist I, Documentation Systems is a position that encompasses several Quality Systems. The position conducts technical quality compliance related activities in accordance with GxP regulations and internal Standard Operating Procedures. Primary responsibilities include coordinating documentation in support of global submissions, routine document revisions, document issuance, and documentation archives.

Core 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.

Education and Experience 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.

Knowledge, Skills And Abilities

• 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.
• 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 Requirements (if applicable)

• 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.

Additional Information

This job description is not intended to be an all-inclusive list of duties and responsibilities and may be modified as business needs require.

We are an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance.

For more information about your rights under Equal Employment Opportunity, visit:

• EEOC Know Your Rights
• USERRA Rights
• Family and Medical Leave Act (FMLA)
• Employee Polygraph Protection Act (EPPA)
• E-Verify (English and Spanish)
• Right to Work (English and Spanish)

We strive to make our Career opportunities website accessible to all users. If you need an accommodation to participate in the application or hiring process, please email the Knoa Pharma LLC Talent Acquisition team at [e-mail]. This email is not for general employment inquiries or vendors; rather it is strictly for applicants who require assistance.

The Company does not seek or accept unsolicited resumes or CVs from recruitment agencies. We are not responsible for any fees, commission, or any type of payment related to unsolicited resumes or CVs except as required in a written agreement between the Company and the recruitment agency or party requesting payment of a fee.

Under certain state law, we may be required to provide a reasonable estimate of the salary range for the jobs covered by this description. Actual salary determinations will take into account factors such as work location, prior education or training and experience, job related knowledge, and demonstrated skills aligned with the Company’s internal leveling guidelines and benchmarks. Resumes may be considered in the order they are received.