BioSpace
Quality Assurance Engineer II - Facilities and Equipment (350)
BioSpace, Virginia State University, Virginia, us, 23806
Quality Assurance Engineer II – Facilities and Equipment (350)
Richmond, VA $115,000.00-$145,000.00 3 days ago
Overview Join Civica, Inc. at our new fill‑finish facility in Petersburg, Virginia. The site manufactures essential generic sterile injectable medications. You will support the launch and ongoing operation of FDA‑approved production of more than thirty injectables and biosimilar insulin.
Responsibilities Responsibilities of the position include maintaining quality systems and oversight to ensure the validation, qualification, and operation of processes, facility, utilities, equipment, and computer systems meet cGMP and Civica compliance requirements at the onset of building the facility, leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.
Responsibilities also include, but are not limited to, the generation, review, and/or approval of policies, procedures, reports, and other records necessary to provide quality oversight of Civica Engineering functions, including validation, qualification, and ongoing operation activities of facility, utilities, processes, equipment, instrumentation, and to ensure FDA requirements are met.
Essential Duties And 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 and ensure work is performed in a compliant and controlled manner.
Maintain current knowledge of local and international regulatory and legislative requirements and trends to provide expert advice and technical support on all quality‑related matters.
Support and ensure compliance of facilities and utilities validation, and requirements from and/or to other manufacturing sites.
Support implementation and quality oversight for overall compliance of the facility, equipment, and manufacturing processes.
Manage quality processes and systems across the product lifecycle, including change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, annual product quality review (APQR), and management notifications.
Provide quality review and support for pest control program, calibration, and maintenance programs, ensuring they are run in accordance with GMP regulations.
Lead or participate in Quality Risk Management and analysis.
Proactively identify and resolve problems using risk‑based and compliant approaches.
Promote a quality mindset and quality excellence approach to all activities.
Promote a safety mindset and focus on safety 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 of 21CFR Part 11, electronic records and signatures, and data integrity.
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 root‑cause investigations.
Leverage experience and share industry best practices to support continuous improvement of site procedures.
Committed to delivering high‑quality results, working with others to overcome challenges, and focusing on what matters.
Continuously look 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 associated implementation strategies.
Technical expertise in sterile pharmaceutical isolator technology, combination product 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.
While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee is frequently required to use their 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.
Equal Opportunity Employer Statement The company is an Equal Opportunity Employer, a drug‑free workplace, and complies with applicable ADA regulations.
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Overview Join Civica, Inc. at our new fill‑finish facility in Petersburg, Virginia. The site manufactures essential generic sterile injectable medications. You will support the launch and ongoing operation of FDA‑approved production of more than thirty injectables and biosimilar insulin.
Responsibilities Responsibilities of the position include maintaining quality systems and oversight to ensure the validation, qualification, and operation of processes, facility, utilities, equipment, and computer systems meet cGMP and Civica compliance requirements at the onset of building the facility, leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.
Responsibilities also include, but are not limited to, the generation, review, and/or approval of policies, procedures, reports, and other records necessary to provide quality oversight of Civica Engineering functions, including validation, qualification, and ongoing operation activities of facility, utilities, processes, equipment, instrumentation, and to ensure FDA requirements are met.
Essential Duties And 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 and ensure work is performed in a compliant and controlled manner.
Maintain current knowledge of local and international regulatory and legislative requirements and trends to provide expert advice and technical support on all quality‑related matters.
Support and ensure compliance of facilities and utilities validation, and requirements from and/or to other manufacturing sites.
Support implementation and quality oversight for overall compliance of the facility, equipment, and manufacturing processes.
Manage quality processes and systems across the product lifecycle, including change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, annual product quality review (APQR), and management notifications.
Provide quality review and support for pest control program, calibration, and maintenance programs, ensuring they are run in accordance with GMP regulations.
Lead or participate in Quality Risk Management and analysis.
Proactively identify and resolve problems using risk‑based and compliant approaches.
Promote a quality mindset and quality excellence approach to all activities.
Promote a safety mindset and focus on safety 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 of 21CFR Part 11, electronic records and signatures, and data integrity.
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 root‑cause investigations.
Leverage experience and share industry best practices to support continuous improvement of site procedures.
Committed to delivering high‑quality results, working with others to overcome challenges, and focusing on what matters.
Continuously look 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 associated implementation strategies.
Technical expertise in sterile pharmaceutical isolator technology, combination product 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.
While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee is frequently required to use their 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.
Equal Opportunity Employer Statement The company is an Equal Opportunity Employer, a drug‑free workplace, and complies with applicable ADA regulations.
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