Quality Assurance Associate

Civica Rx; Petersburg (VA); Sur place; USD 75 000 - 110 000; Plein temps

Résumé du poste

Civica Rx in Petersburg, Virginia, seeks a Quality Assurance Operations Shop Floor Associate on 2nd shift to ensure cGMP compliance on the manufacturing floor of the fill-finish facility. You will oversee procedures, batch records, aseptic technique, and nonconformances, while collaborating with operators and supervisors to resolve discrepancies.

Ideal candidates have a science degree and 2+ years in a cGMP manufacturing environment, with experience in sterile isolator tech or medical devices,

Qualifications

• Bachelor's degree in a scientific discipline.
• Minimum of 2+ years of experience in pharmaceutical, biotech, cell therapy, or medical device cGMP manufacturing.
• Experience in sterile pharmaceutical isolator technology, combination products, or medical devices.
• Demonstrated experience delivering training on cGMP regulations, SOPs, and quality systems.
• Excellent written and verbal skills and ability to present technical data effectively.

Responsabilités

• Provide Quality Assurance oversight on the manufacturing floor during all operations regarding procedures, reports, batch records, aseptic technique, gowning, nonconformances, product sampling, and/or other records as necessary to support the manufacturing processes.
• On-the-floor review of batch records during execution to ensure compliance with approved procedures, and communicate and resolve discrepancies with operators and supervisors.
• Familiarity with electronic management systems such as Veeva, Deacom, and Blue Mountain RAM.
• Facilitate Quality oversight on the shop floor through walkthroughs, Gemba, and process observations to ensure full adherence to cGMP practices.
• Identify and implement improvements to procedures and processes as part of broader continuous improvement initiatives.
• Working across functions to ensure operational compliance in all aspects of product manufacturing.
• Enforcing adherence to all Civica SOPs while on the manufacturing floor.
• Promote a quality mindset and quality excellence approach to all activities.
• Promote a safety mindset and focus on safety for all operations activities.
• Ensure that on-the-floor review of manufacturing records, batch quantities, and accountability calculations are performed and completed accurately.
• Provide immediate support in the identification and documentation of nonconformances, deviations, or discrepancies on the manufacturing floor.
• Provide support as required to all manufacturing and processing areas within the facility, depending on job assignment and schedule.

Connaissances

QA oversight

Training delivery

cGMP regulations

Verbal communication

Formation

Bachelor's degree in a scientific discipline

Outils

Veeva

Deacom

Blue Mountain RAM

Description du poste

The Quality Assurance Operations Shop Floor Associate 2nd shift is part of the Quality Assurance Operations team at Civica’s Petersburg, Virginia manufacturing facility. The Petersburg site serves as Civica’s new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications. This role will function to ensure ongoing compliance with cGMP requirements on the manufacturing floor.

Key Responsibilities:

• Provide Quality Assurance oversight on the manufacturing floor during all operations regarding procedures, reports, batch records, aseptic technique, gowning, nonconformances, product sampling, and/or other records as necessary to support the manufacturing processes.
• On-the-floor review of batch records during execution to ensure compliance with approved procedures, as well as communicate and resolve discrepancies with manufacturing operators and/or supervisors.
• Familiarity with electronic management systems such as Veeva, Deacom, and Blue Mountain RAM.
• Facilitate Quality oversight on the shop floor through walkthroughs, Gemba, and process observations to ensure full adherence to cGMP practices.
• Identify and implement improvements to procedures and processes as part of broader continuous improvement initiatives.

Essential Duties and Responsibilities:

• Working across functions to ensure operational compliance in all aspects of product manufacturing.
• Enforcing adherence to all Civica standard operating procedures (SOPs) while on the manufacturing floor.
• Promote a quality mindset and quality excellence approach to all activities.
• Promote a safety mindset and focus on safety for all operations activities.
• Ensure that on-the-floor review of manufacturing records, batch quantities, and accountability calculations are performed and completed accurately.
• Provide immediate support in the identification and documentation of nonconformances, deviations, or discrepancies on the manufacturing floor.
• Provide support as required to all manufacturing and processing areas within the facility, depending on job assignment and schedule.

Basic Qualifications and Capabilities:

• Bachelor's degree or above in a scientific discipline.
• Minimum of 2+ years of experience within a pharmaceutical, biotech, cell therapy, or medical device cGMP-regulated manufacturing environment.
• Experience in sterile pharmaceutical isolator technology, combination products, or medical devices.
• Demonstrated experience delivering training on cGMP regulations, SOPs, and quality systems.
• Excellent written and verbal skills and ability to present technical data effectively based on target audience.
• Ability to work in a fast-paced team environment and lead peers through changing priorities.
• Detail-oriented and task-focused with the ability to meet deadlines and support work prioritization.

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 accommodations 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 this position requires 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, a drug-free workplace, and complies with ADA regulations as applicable.