QRC Group is seeking an experienced Quality Assurance Engineer to provide oversight and quality leadership for a major Grade D Manufacturing Environment project at a sterile combination drug/device manufacturing facility.
This individual will serve as the Quality Assurance Engineer for the project supporting the implementation of a Central Dust Extraction system Grade D manufacturing area and suite build-out and equipment relocation and validation activities. The selected candidate will review approve and sign validation and quality documentation while ensuring compliance with applicable cGMP regulations data integrity requirements and site quality standards.
Key Responsibilities
Provide Quality Assurance oversight for the Grade D Manufacturing Environment project including:
Central Dust Extraction System implementation
Grade D area and suite construction activities
Equipment relocation and validation efforts
Review approve and sign validation protocols reports and manufacturing documentation on behalf of Quality Assurance.
Serve as the primary QA resource for technical and compliance-related questions from Engineering Manufacturing Validation and Project teams.
Support environmental monitoring (EM) bioburden contamination-control and cleanroom compliance programs for Grade C and Grade D classified areas.
Review and approve cleaning validation documentation including master plans protocols sampling strategies and acceptance criteria.
Support deviation investigations root cause analyses CAPA development and quality risk assessments.
Ensure compliance with cGMP requirements company procedures and data integrity principles (ALCOA).
Participate in facility qualification equipment qualification and validation activities.
Provide QA support during audits inspections and regulatory readiness activities.
Collaborate cross-functionally to ensure project milestones are achieved while maintaining the highest quality standards.
Requirements
Bachelors degree in Engineering Life Sciences or a related scientific discipline.
Minimum of 8 years of Quality Assurance experience within sterile pharmaceutical aseptic manufacturing or combination drug/device environments.
Strong working knowledge of:
cGMP regulations (21 CFR Parts 210 and 211)
Quality systems and compliance requirements
Environmental Monitoring (EM) and bioburden programs
Cleaning validation principles and documentation
Experience reviewing and approving validation protocols reports and GMP documentation.
Hands-on experience supporting Grade C and/or Grade D cleanroom operations.
Strong technical writing documentation review and problem-solving skills.
Excellent communication and stakeholder management abilities.
Fully bilingual inEnglish and Spanish.
Required Skills:
Bachelors degree in Engineering Life Sciences or a related scientific discipline. Minimum of 8 years of Quality Assurance experience within sterile pharmaceutical aseptic manufacturing or combination drug/device environments. Strong working knowledge of: cGMP regulations (21 CFR Parts 210 and 211) Quality systems and compliance requirements Environmental Monitoring (EM) and bioburden programs Cleaning validation principles and documentation Experience reviewing and approving validation protocols reports and GMP documentation. Hands-on experience supporting Grade C and/or Grade D cleanroom operations. Strong technical writing documentation review and problem-solving skills. Excellent communication and stakeholder management abilities. Fully bilingual in English and Spanish.
QRC Group is seeking an experienced Quality Assurance Engineer to provide oversight and quality leadership for a major Grade D Manufacturing Environment project at a sterile combination drug/device manufacturing facility.This individual will serve as the Quality Assurance Engineer for the project su...
QRC Group is seeking an experienced Quality Assurance Engineer to provide oversight and quality leadership for a major Grade D Manufacturing Environment project at a sterile combination drug/device manufacturing facility.
This individual will serve as the Quality Assurance Engineer for the project supporting the implementation of a Central Dust Extraction system Grade D manufacturing area and suite build-out and equipment relocation and validation activities. The selected candidate will review approve and sign validation and quality documentation while ensuring compliance with applicable cGMP regulations data integrity requirements and site quality standards.
Key Responsibilities
Provide Quality Assurance oversight for the Grade D Manufacturing Environment project including:
Central Dust Extraction System implementation
Grade D area and suite construction activities
Equipment relocation and validation efforts
Review approve and sign validation protocols reports and manufacturing documentation on behalf of Quality Assurance.
Serve as the primary QA resource for technical and compliance-related questions from Engineering Manufacturing Validation and Project teams.
Support environmental monitoring (EM) bioburden contamination-control and cleanroom compliance programs for Grade C and Grade D classified areas.
Review and approve cleaning validation documentation including master plans protocols sampling strategies and acceptance criteria.
Support deviation investigations root cause analyses CAPA development and quality risk assessments.
Ensure compliance with cGMP requirements company procedures and data integrity principles (ALCOA).
Participate in facility qualification equipment qualification and validation activities.
Provide QA support during audits inspections and regulatory readiness activities.
Collaborate cross-functionally to ensure project milestones are achieved while maintaining the highest quality standards.
Requirements
Bachelors degree in Engineering Life Sciences or a related scientific discipline.
Minimum of 8 years of Quality Assurance experience within sterile pharmaceutical aseptic manufacturing or combination drug/device environments.
Strong working knowledge of:
cGMP regulations (21 CFR Parts 210 and 211)
Quality systems and compliance requirements
Environmental Monitoring (EM) and bioburden programs
Cleaning validation principles and documentation
Experience reviewing and approving validation protocols reports and GMP documentation.
Hands-on experience supporting Grade C and/or Grade D cleanroom operations.
Strong technical writing documentation review and problem-solving skills.
Excellent communication and stakeholder management abilities.
Fully bilingual inEnglish and Spanish.
Required Skills:
Bachelors degree in Engineering Life Sciences or a related scientific discipline. Minimum of 8 years of Quality Assurance experience within sterile pharmaceutical aseptic manufacturing or combination drug/device environments. Strong working knowledge of: cGMP regulations (21 CFR Parts 210 and 211) Quality systems and compliance requirements Environmental Monitoring (EM) and bioburden programs Cleaning validation principles and documentation Experience reviewing and approving validation protocols reports and GMP documentation. Hands-on experience supporting Grade C and/or Grade D cleanroom operations. Strong technical writing documentation review and problem-solving skills. Excellent communication and stakeholder management abilities. Fully bilingual in English and Spanish.
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