Job Description:

The Quality Systems Specialist will join Civica, Inc. (“Civica”) at the Petersburg, Virginia site, bringing knowledge and experience in service to patients and in support of excellence in quality and compliance. The Petersburg site serves as Civica’s fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

Responsibilities of the position include, but are not limited to, supporting the execution, coordination, and continuous improvement of site Quality Systems across multiple quality system functions. In a cross-trained team environment, the Quality Systems Specialist will contribute to processes including Change Control, deviations, investigations, CAPA, self-inspection, supplier quality, complaints, and other quality system activities, as needed. This role is essential to maintaining compliance with applicable regulatory standards, including current Good Manufacturing Practices, and to supporting inspection readiness and the reliable supply of quality medicines to patients.

Essential Duties and Responsibilities:

·     Support the execution, coordination, and continuous improvement of site Quality Systems within a cross-trained team environment, serving as a primary contact or subject matter resource for assigned areas as needed.

·     Perform and support activities across multiple quality system functions, including but not limited to change control, deviations/investigations, CAPA, internal audit/self-inspection, supplier quality, complaints, and related quality processes.

·     Review, edit, coordinate, and maintain quality system records and documentation to ensure compliance with cGMP, regulatory, and internal procedure requirements.

·     Facilitate or support cross-functional meetings and follow-up activities to help drive timely progress and completion of assigned quality system deliverables.

·     Monitor assigned quality system activities for timeliness, completeness, and compliance, escalating issues as appropriate.

·     Track, trend, and analyze quality system metrics to support routine reporting, identify issues, and contribute to continuous improvement efforts.

·     Apply applicable procedures, regulatory requirements, and quality standards to support consistent execution of quality system processes and resolution of routine and moderately complex issues.

·     Build collaborative working relationships across departments to provide day-to-day guidance and promote understanding of quality system requirements and standard processes.

·     Author, revise, and support implementation of procedures, work practices, and other controlled documents within area of responsibility.

·     Participate in inspection readiness activities, internal audits/self-inspections, supplier quality activities, and regulatory inspection support as needed.

·     Support supplier qualification, monitoring, and related quality activities, including participation in investigations, audit CAPA follow-up, and quality agreement support, as applicable.

·     Support the management of complaints and pharmacovigilance-related records and activities, as applicable, in accordance with site procedures and health authority requirements.

·     Identify risks, raise quality concerns appropriately, and work collaboratively with cross-functional partners to implement practical, compliant, and risk-based solutions.

·     Provide informal guidance, training, and knowledge sharing to peers and new team members across the Quality Systems team.

·     Continue building functional and technical expertise across quality systems to support team flexibility, process consistency, and business needs.

·     Promote a culture of quality, safety, compliance, and continuous improvement in all activities.

Basic Qualifications and Capabilities:

·      A minimum of 4 years of combined technical experience in a GMP related field within a pharmaceutical, biologics, or medical device manufacturing facility.

·      Experience with Quality systems and demonstrated working knowledge in areas such as material/process controls, supplier quality management, audits, change control, deviation, CAPA, Management Review.

·      Experience with cGMPs and Quality System regulatory requirements.

·      Experience with Quality computerized system applications (e.g., Veeva, Deacom)

·      Works on multiple assignments in collaboration with various department system owners.

·      Excellent interpersonal, verbal and written (including editing) communication skills are crucial in this collaborative work environment.

·      Ability to communicate and work independently with scientific/technical personnel.

·      Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

·      Strong organization, and execution skills with attention to detail.

·      Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.

·      Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate. 

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.