Katalyst CRO
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QA, Senior Specialist
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Katalyst CRO 4 months ago Be among the first 25 applicants Join to apply for the
QA, Senior Specialist
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Ensure distribution licenses (where required) accurately reflect the current organization, vary license where necessary. Support recalls, mock recalls and any other on-market activity. Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions. Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches. Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Distribution licenses (or equivalent) application, audits, and Quality Agreements. Planning/ Preparation/supporting/hosting for Regulatory inspections. Providing front and backroom inspection support. Post inspection follow-up with responses and CAPAs (Continuous improvements). Manage/Approve/Assess event investigations "deviations” (including Fast Track deviations). Manage CAPAs and Effectiveness Checks. Perform other duties as per GDP guidelines and company policies and procedures. Work with company's Product Complaints team to ensure that customer complaints are dealt with effectively. Ensure that customers and suppliers are approved. Approving any subcontracting activities that may impact GDP. Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place. Deciding on the final disposition of returned, rejected, recalled or counterfeit medicines, including the approval of returns to saleable stock. Ensure that any additional requirements imposed on certain products by national law are adhered to. Create/review and approve Standard operating Procedures and other Quality Documents.
The following information provides an overview of the skills, qualities, and qualifications needed for this role.
Responsibilities
Ensure distribution licenses (where required) accurately reflect the current organization, vary license where necessary. Support recalls, mock recalls and any other on-market activity. Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions. Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches. Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Distribution licenses (or equivalent) application, audits, and Quality Agreements. Planning/ Preparation/supporting/hosting for Regulatory inspections. Providing front and backroom inspection support. Post inspection follow-up with responses and CAPAs (Continuous improvements). Manage/Approve/Assess event investigations "deviations” (including Fast Track deviations). Manage CAPAs and Effectiveness Checks. Perform other duties as per GDP guidelines and company policies and procedures. Work with company's Product Complaints team to ensure that customer complaints are dealt with effectively. Ensure that customers and suppliers are approved. Approving any subcontracting activities that may impact GDP. Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place. Deciding on the final disposition of returned, rejected, recalled or counterfeit medicines, including the approval of returns to saleable stock. Ensure that any additional requirements imposed on certain products by national law are adhered to. Create/review and approve Standard operating Procedures and other Quality Documents.
Requirements:
Bachelors in a scientific or allied health field and relevant GDP & GMP work experience, or relevant comparable background. 5+ years' experience serving in a Quality role. Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP. Influencing skills in areas with no direct reporting authority. Strong interpersonal and communication skills. Auditing skills, appropriate qualifications in auditing an advantage. Fluency in English is required. Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint) Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions Preparation and maintenance of Quality Agreements. Review of deviations, CAPA and changes. Maintaining KPIs. Analyze, resolve, or assist in solving compliance and customer issues. Escalation of issues. Finish Goods Release at 3PL. Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS. Accountable for New Product Launch activities within the US providing distribution requirements and expectations. Working collaboratively with key internal stakeholders. Support Clinical QA Distribution. GDP. Distribution. Logistics. Industry experience. Good Group fit. QA background. QMS, CAPA. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeContract Job function
Job functionQuality Assurance IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Senior Quality Assurance Specialist” roles.Manager, Quality Assurance (QA), Global QMS Canton, MA $70,000.00-$90,000.00 1 week ago Sr. Manager, Global Pharmacovigilance Auditing / Quality AssuranceQuality Assurance Specialist/Manager – Bioanalytical LaboratoryAssurance Experienced Senior, Quality ManagementClient Experience Manager - Quality Assurance Mansfield, MA $75,600.00-$108,000.00 1 day ago Marlborough, MA $94,000.00-$118,000.00 1 month ago Woburn, MA $120,000.00-$140,000.00 2 days ago Quality Assurance Senior Manager, Technical Life Cycle Management (Cell and Genetic Therapies)Assurance Manager, Quality Management - IS AssuranceSr. QC Consultant- Data Evaluation and Specification 2081255 Mansfield, MA $115,900.00-$173,800.00 1 day ago Lab Quality Assurance and Standards LeadManager - Quality Assurance & Food SafetyFood Safety & Quality Assurance Manager (Relocation Available)Sr. QC Consultant- Data Evaluation and SpecificationAssociate Director, Biomedicine Clinical Quality Assurance *PC 1485 Waltham, MA $145,400.00-$196,700.00 1 month ago Registered Psychiatric Nurse Team Leader Boston, MA $91,000.00-$253,700.00 5 days ago Burlington, MA $90,000.00-$142,500.00 2 days ago Burlington, MA $80,000.00-$132,500.00 3 weeks ago Associate Director/ Director, Quality Assurance North Andover, MA $70,000.00-$80,000.00 1 day ago Sr. Quality Assurance Specialist for Service Enablement Cambridge, MA $109,000.00-$168,000.00 6 days ago Senior Manager, Global Pharmacovigilance (PV) Quality AssuranceSenior Manager, Global Pharmacovigilance (PV) Quality Assurance We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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QA, Senior Specialist
role at
Katalyst CRO 4 months ago Be among the first 25 applicants Join to apply for the
QA, Senior Specialist
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Ensure distribution licenses (where required) accurately reflect the current organization, vary license where necessary. Support recalls, mock recalls and any other on-market activity. Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions. Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches. Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Distribution licenses (or equivalent) application, audits, and Quality Agreements. Planning/ Preparation/supporting/hosting for Regulatory inspections. Providing front and backroom inspection support. Post inspection follow-up with responses and CAPAs (Continuous improvements). Manage/Approve/Assess event investigations "deviations” (including Fast Track deviations). Manage CAPAs and Effectiveness Checks. Perform other duties as per GDP guidelines and company policies and procedures. Work with company's Product Complaints team to ensure that customer complaints are dealt with effectively. Ensure that customers and suppliers are approved. Approving any subcontracting activities that may impact GDP. Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place. Deciding on the final disposition of returned, rejected, recalled or counterfeit medicines, including the approval of returns to saleable stock. Ensure that any additional requirements imposed on certain products by national law are adhered to. Create/review and approve Standard operating Procedures and other Quality Documents.
The following information provides an overview of the skills, qualities, and qualifications needed for this role.
Responsibilities
Ensure distribution licenses (where required) accurately reflect the current organization, vary license where necessary. Support recalls, mock recalls and any other on-market activity. Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions. Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches. Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Distribution licenses (or equivalent) application, audits, and Quality Agreements. Planning/ Preparation/supporting/hosting for Regulatory inspections. Providing front and backroom inspection support. Post inspection follow-up with responses and CAPAs (Continuous improvements). Manage/Approve/Assess event investigations "deviations” (including Fast Track deviations). Manage CAPAs and Effectiveness Checks. Perform other duties as per GDP guidelines and company policies and procedures. Work with company's Product Complaints team to ensure that customer complaints are dealt with effectively. Ensure that customers and suppliers are approved. Approving any subcontracting activities that may impact GDP. Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place. Deciding on the final disposition of returned, rejected, recalled or counterfeit medicines, including the approval of returns to saleable stock. Ensure that any additional requirements imposed on certain products by national law are adhered to. Create/review and approve Standard operating Procedures and other Quality Documents.
Requirements:
Bachelors in a scientific or allied health field and relevant GDP & GMP work experience, or relevant comparable background. 5+ years' experience serving in a Quality role. Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP. Influencing skills in areas with no direct reporting authority. Strong interpersonal and communication skills. Auditing skills, appropriate qualifications in auditing an advantage. Fluency in English is required. Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint) Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions Preparation and maintenance of Quality Agreements. Review of deviations, CAPA and changes. Maintaining KPIs. Analyze, resolve, or assist in solving compliance and customer issues. Escalation of issues. Finish Goods Release at 3PL. Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS. Accountable for New Product Launch activities within the US providing distribution requirements and expectations. Working collaboratively with key internal stakeholders. Support Clinical QA Distribution. GDP. Distribution. Logistics. Industry experience. Good Group fit. QA background. QMS, CAPA. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeContract Job function
Job functionQuality Assurance IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Senior Quality Assurance Specialist” roles.Manager, Quality Assurance (QA), Global QMS Canton, MA $70,000.00-$90,000.00 1 week ago Sr. Manager, Global Pharmacovigilance Auditing / Quality AssuranceQuality Assurance Specialist/Manager – Bioanalytical LaboratoryAssurance Experienced Senior, Quality ManagementClient Experience Manager - Quality Assurance Mansfield, MA $75,600.00-$108,000.00 1 day ago Marlborough, MA $94,000.00-$118,000.00 1 month ago Woburn, MA $120,000.00-$140,000.00 2 days ago Quality Assurance Senior Manager, Technical Life Cycle Management (Cell and Genetic Therapies)Assurance Manager, Quality Management - IS AssuranceSr. QC Consultant- Data Evaluation and Specification 2081255 Mansfield, MA $115,900.00-$173,800.00 1 day ago Lab Quality Assurance and Standards LeadManager - Quality Assurance & Food SafetyFood Safety & Quality Assurance Manager (Relocation Available)Sr. QC Consultant- Data Evaluation and SpecificationAssociate Director, Biomedicine Clinical Quality Assurance *PC 1485 Waltham, MA $145,400.00-$196,700.00 1 month ago Registered Psychiatric Nurse Team Leader Boston, MA $91,000.00-$253,700.00 5 days ago Burlington, MA $90,000.00-$142,500.00 2 days ago Burlington, MA $80,000.00-$132,500.00 3 weeks ago Associate Director/ Director, Quality Assurance North Andover, MA $70,000.00-$80,000.00 1 day ago Sr. Quality Assurance Specialist for Service Enablement Cambridge, MA $109,000.00-$168,000.00 6 days ago Senior Manager, Global Pharmacovigilance (PV) Quality AssuranceSenior Manager, Global Pharmacovigilance (PV) Quality Assurance We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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