Job Description:

The Associate QC Analyst Incoming Second Shift will join the Civica, Inc. (“Civica”) organization and its newly forming team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica’s new fill-finish facility dedicated to manufacturing and supplying essential generic sterile injectable medications.  

The role is essential to ensure the Petersburg site’s manufacturing and operations activities comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices) and expectations for the development and reliable supply of quality medicines. 

The position’s responsibilities include, but are not limited to, overseeing the incoming sampling process, supporting quality control (QC) operations, performing QC testing, and conducting and documenting incoming inspection and sampling activities of components and raw materials. 

Essential Duties and Responsibilities:

• Conduct and document material, component, and packaging sampling according to the established sampling plans. 

• Support the development of sampling plans across the product lifecycle. 

• Conduct sampling according to established procedures 

• Support and participate in testing and Acceptable Quality Level (AQL) checks and document the results using proper documentation practices. 

• Ensure that all aspects of the handling and manufacturing of pharmaceutical products at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements. 

• Support the shipment of samples to the appropriate external testing facilities as needed. 

• Complete laboratory inventory and ordering supplies as required. 

• Participate and/or lead various Quality Systems processes including change controls, investigations, and corrective and preventative action (CAPA) plans. 

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

• Practice and promote a safety and quality mindset and quality excellence approach to all activities. 

• Work across functions to support the development and maintenance of incoming sample management.

• Assist with other departmental duties as assigned.

• This position will be working on the second shift. Training will occur on the first shift until the transition to the second shift.

Basic Qualifications and Capabilities:

• Bachelor’s degree in a scientific discipline with a minimum of 3 years of Quality/CGMP experience in the pharmaceutical industry.  

• Excellent written/oral communication skills with strong discipline in Microsoft programs are required. 

• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.

• Ability to work autonomously within established guidelines, procedures, and practices. 

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 and to wear PPE. The employee is required to stand; walk; sit; and reach with hands and arms. The employee must lift and/or move up to 50 pounds. Specific vision abilities required by this position include color vision, 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, a drug-free workplace, and complies with ADA regulations as applicable. 

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