Validation & Engineering Group, Inc.
LL01-093024 Quality Assurance Specialist
Validation & Engineering Group, Inc., Juncos, Juncos, us, 00777
LL01-093024 Quality Assurance Specialist
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Validation & Engineering Group, Inc. (V&EG)
is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Quality Assurance Specialist
Key Responsibilities
Ensure compliance with GMP, FDA, and other regulatory standards.
Oversee quality systems for manufacturing, packaging, and testing.
Collaborate with cross-functional teams to ensure product quality and process efficiency.
Review and approve quality-related documentation, including batch records, SOPs, deviations, change controls, and CAPAs.
Maintain accurate and up-to-date records of all QA activities.
Conduct internal and external audits to assess compliance with quality standards.
Prepare for and participate in regulatory inspections and customer audits.
Provide support during regulatory submissions, such as those for the FDA, EMA, or other regulatory bodies.
Monitor production processes to ensure adherence to quality standards.
Investigate quality-related issues, deviations, and non-conformances, implementing appropriate corrective actions.
Support continuous improvement initiatives in quality processes and procedures.
Review and approve validation protocols or batch records for product release, ensuring that all critical quality attributes are met.
Conduct risk assessments to identify potential quality issues and propose mitigations.
Support the implementation of risk-based approaches in quality management processes.
Stay updated on industry trends, regulatory changes, and new quality assurance techniques.
Qualifications
Bachelor’s degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field.
5+ years of experience in quality assurance in a biotechnology, pharmaceutical, or life sciences environment.
In-depth knowledge of GMP, FDA regulations, and quality systems in the biotech/pharmaceutical industry.
Strong problem-solving and analytical skills.
Excellent written and verbal communication skills.
Proficiency in quality management software and systems (e.g., LIMS, QMS).
Preferred Qualifications
Experience with biological product manufacturing.
Familiarity with quality assurance in a clinical setting.
Certification in Quality Assurance (e.g., ASQ certification).
Key Competencies
Attention to detail.
Strong organizational skills.
Ability to work independently and as part of a team.
Critical thinking and decision-making.
Seniority level: Not Applicable
Employment type: Full-time
Job function: Strategy/Planning and Information Technology
Referrals increase your chances of interviewing at Validation & Engineering Group, Inc. by 2x
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Juncos, Puerto Rico .
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Get AI-powered advice on this job and more exclusive features.
Validation & Engineering Group, Inc. (V&EG)
is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Quality Assurance Specialist
Key Responsibilities
Ensure compliance with GMP, FDA, and other regulatory standards.
Oversee quality systems for manufacturing, packaging, and testing.
Collaborate with cross-functional teams to ensure product quality and process efficiency.
Review and approve quality-related documentation, including batch records, SOPs, deviations, change controls, and CAPAs.
Maintain accurate and up-to-date records of all QA activities.
Conduct internal and external audits to assess compliance with quality standards.
Prepare for and participate in regulatory inspections and customer audits.
Provide support during regulatory submissions, such as those for the FDA, EMA, or other regulatory bodies.
Monitor production processes to ensure adherence to quality standards.
Investigate quality-related issues, deviations, and non-conformances, implementing appropriate corrective actions.
Support continuous improvement initiatives in quality processes and procedures.
Review and approve validation protocols or batch records for product release, ensuring that all critical quality attributes are met.
Conduct risk assessments to identify potential quality issues and propose mitigations.
Support the implementation of risk-based approaches in quality management processes.
Stay updated on industry trends, regulatory changes, and new quality assurance techniques.
Qualifications
Bachelor’s degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field.
5+ years of experience in quality assurance in a biotechnology, pharmaceutical, or life sciences environment.
In-depth knowledge of GMP, FDA regulations, and quality systems in the biotech/pharmaceutical industry.
Strong problem-solving and analytical skills.
Excellent written and verbal communication skills.
Proficiency in quality management software and systems (e.g., LIMS, QMS).
Preferred Qualifications
Experience with biological product manufacturing.
Familiarity with quality assurance in a clinical setting.
Certification in Quality Assurance (e.g., ASQ certification).
Key Competencies
Attention to detail.
Strong organizational skills.
Ability to work independently and as part of a team.
Critical thinking and decision-making.
Seniority level: Not Applicable
Employment type: Full-time
Job function: Strategy/Planning and Information Technology
Referrals increase your chances of interviewing at Validation & Engineering Group, Inc. by 2x
Get notified about new Quality Assurance Specialist jobs in
Juncos, Puerto Rico .
#J-18808-Ljbffr