Civica Rx
Quality Assurance Engineer II - Facilities and Equipment (350)
Civica Rx, Virginia State University, Virginia, us, 23806
Overview
Quality Assurance Engineer II - Facilities and Equipment located in Petersburg, Virginia. The Quality Engineer II will join the Civica, Inc. Quality organization to support the validation/qualification and operation of processes, facilities, utilities, equipment, and computer systems to meet cGMP and Civica compliance, with the aim of FDA approvals and ongoing regulatory compliance.
Responsibilities
Work across functional groups to ensure the site’s quality system processes related to GMP compliance of the facility, equipment, computer systems, and processes.
Provide Quality oversight for validation and qualification activities with engineering teams to ensure work is performed in a compliant and controlled manner.
Maintain current knowledge of local and international regulatory requirements and provide expert advice and technical support on quality-related matters at the site.
Support and ensure compliance of facilities and utilities validation, and requirements to/from other manufacturing sites.
Support implementation and quality oversight of overall compliance of the facility, equipment, and manufacturing processes.
Support quality processes and systems across the product lifecycle, including change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, APQR, and management notification.
Provide quality review and support for pest control, calibration, and maintenance programs, ensuring alignment with GMP regulations.
Lead or participate in Quality Risk Management and analysis.
Proactively identify and collaboratively resolve problems using risk-based, compliant approaches.
Promote a quality mindset and safety mindset for all operational activities.
Travel up to 5% may be required.
Basic Qualifications And Capabilities
Bachelor’s degree in a scientific discipline with a minimum of 6 years of quality/cGMP experience in the pharmaceutical industry.
Experience in facility and equipment qualification, process validation, LIMS systems, and calibration and maintenance programs.
Knowledge in 21CFR Part 11, Electronic Records and Signatures, and data integrity is required.
Strong project management, organization, and execution skills to manage multiple projects and priorities.
Participation and leading activities to support regulatory agency inspections.
Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
Ability to work autonomously and within established guidelines, procedures, and practices.
Serve as a Quality subject matter expert to support driving investigations to root cause.
Leverage experience and share industry best practices to support continuous improvement of site procedures.
Committed to delivering high-quality results, collaborating with others to overcome challenges, and focusing on critical priorities.
Continuously looking for opportunities to learn, build skills, and share knowledge with others.
Excellent interpersonal and written communication skills and experience using various software/electronic applications.
Preferred Qualifications
Experience across the product development and commercialization lifecycle, including change management and implementation strategies.
Technical expertise in sterile pharmaceutical isolator technology, and in combination products and medical devices.
Physical Demands And Work Environment The physical demands described here are representative of those that an employee must meet to perform the essential functions of this position successfully. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions. The employee is regularly required to speak or hear, use hands, and handle tools or controls. May be required to stand, walk, sit, and reach. May lift and/or move up to 25 pounds. Specific vision abilities required include close and distance vision and the ability to adjust focus. The noise level is usually low to moderate.
The company is an Equal Opportunity Employer, a drug-free workplace, and complies with applicable ADA regulations.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Civica Rx. Get notified about new Quality Assurance Engineer jobs in Petersburg, VA.
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Responsibilities
Work across functional groups to ensure the site’s quality system processes related to GMP compliance of the facility, equipment, computer systems, and processes.
Provide Quality oversight for validation and qualification activities with engineering teams to ensure work is performed in a compliant and controlled manner.
Maintain current knowledge of local and international regulatory requirements and provide expert advice and technical support on quality-related matters at the site.
Support and ensure compliance of facilities and utilities validation, and requirements to/from other manufacturing sites.
Support implementation and quality oversight of overall compliance of the facility, equipment, and manufacturing processes.
Support quality processes and systems across the product lifecycle, including change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, APQR, and management notification.
Provide quality review and support for pest control, calibration, and maintenance programs, ensuring alignment with GMP regulations.
Lead or participate in Quality Risk Management and analysis.
Proactively identify and collaboratively resolve problems using risk-based, compliant approaches.
Promote a quality mindset and safety mindset for all operational activities.
Travel up to 5% may be required.
Basic Qualifications And Capabilities
Bachelor’s degree in a scientific discipline with a minimum of 6 years of quality/cGMP experience in the pharmaceutical industry.
Experience in facility and equipment qualification, process validation, LIMS systems, and calibration and maintenance programs.
Knowledge in 21CFR Part 11, Electronic Records and Signatures, and data integrity is required.
Strong project management, organization, and execution skills to manage multiple projects and priorities.
Participation and leading activities to support regulatory agency inspections.
Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
Ability to work autonomously and within established guidelines, procedures, and practices.
Serve as a Quality subject matter expert to support driving investigations to root cause.
Leverage experience and share industry best practices to support continuous improvement of site procedures.
Committed to delivering high-quality results, collaborating with others to overcome challenges, and focusing on critical priorities.
Continuously looking for opportunities to learn, build skills, and share knowledge with others.
Excellent interpersonal and written communication skills and experience using various software/electronic applications.
Preferred Qualifications
Experience across the product development and commercialization lifecycle, including change management and implementation strategies.
Technical expertise in sterile pharmaceutical isolator technology, and in combination products and medical devices.
Physical Demands And Work Environment The physical demands described here are representative of those that an employee must meet to perform the essential functions of this position successfully. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions. The employee is regularly required to speak or hear, use hands, and handle tools or controls. May be required to stand, walk, sit, and reach. May lift and/or move up to 25 pounds. Specific vision abilities required include close and distance vision and the ability to adjust focus. The noise level is usually low to moderate.
The company is an Equal Opportunity Employer, a drug-free workplace, and complies with applicable ADA regulations.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Civica Rx. Get notified about new Quality Assurance Engineer jobs in Petersburg, VA.
#J-18808-Ljbffr