Katalyst CRO
Join to apply for the
Quality Assurance (QA) Specialist
role at
Katalyst CRO Join to apply for the
Quality Assurance (QA) Specialist
role at
Katalyst CRO Monitor compliance with GMP, FDA, and regulatory requirements throughout manufacturing. Conduct inspections, audits, and testing to ensure products meet quality standards. Review batch records, documentation, and processes for compliance with quality protocols. Investigate deviations, non-conformances, and customer complaints, implementing corrective actions. Assist with the preparation for regulatory audits and inspections. Support the development and maintenance of quality assurance systems and procedures. Collaborate with cross-functional teams to resolve quality issues and improve processes. Review and update Standard Operating Procedures (SOPs), batch records, and documentation. Train staff on GMP guidelines and company quality policies.
Read on to find out what you will need to succeed in this position, including skills, qualifications, and experience.
Responsibilities
Monitor compliance with GMP, FDA, and regulatory requirements throughout manufacturing. Conduct inspections, audits, and testing to ensure products meet quality standards. Review batch records, documentation, and processes for compliance with quality protocols. Investigate deviations, non-conformances, and customer complaints, implementing corrective actions. Assist with the preparation for regulatory audits and inspections. Support the development and maintenance of quality assurance systems and procedures. Collaborate with cross-functional teams to resolve quality issues and improve processes. Review and update Standard Operating Procedures (SOPs), batch records, and documentation. Train staff on GMP guidelines and company quality policies.
Requirements:
Bachelor's degree in Pharmaceutical Sciences, Life Sciences, Chemistry, or a related field. 2+ years of experience in Quality Assurance, preferably in the pharmaceutical or biotechnology industry. Strong understanding of GMP, FDA regulations, and industry standards. Experience with pharmaceutical manufacturing processes and quality control testing. Strong attention to detail and communication skills. Proficiency with Microsoft Office Suite; experience with quality management software is a plus. Seniority level
Seniority levelAssociate Employment type
Employment typeContract Job function
Job functionQuality Assurance IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Quality Assurance Specialist jobs in
Boston, MA . QA Specialist II, Validation, Contractor Cambridge, MA $67,151.00 - $79,460.00 2 weeks ago Boston, MA $71,453.20 - $102,351.00 1 month ago Canton, MA $70,000.00 - $85,000.00 1 day ago Lowell, MA $105,000.00 - $125,000.00 5 days ago Marlborough, MA $130,000.00 - $155,000.00 3 weeks ago Senior Manager, Global Pharmacovigilance (PV) Quality AssuranceQuality Assurance & Communications SpecialistAssociate Director, Quality Assurance GMP Training Management Bedford, MA $175,800 - $217,100 1 week ago Quality Control Aerospace Manufacturing (Multiple shifts)Quality Assurance Specialist, Cellular TherapyAssociate Director, Quality Assurance – Facilities Management Bedford, MA $179,400 - $221,700 5 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Quality Assurance (QA) Specialist
role at
Katalyst CRO Join to apply for the
Quality Assurance (QA) Specialist
role at
Katalyst CRO Monitor compliance with GMP, FDA, and regulatory requirements throughout manufacturing. Conduct inspections, audits, and testing to ensure products meet quality standards. Review batch records, documentation, and processes for compliance with quality protocols. Investigate deviations, non-conformances, and customer complaints, implementing corrective actions. Assist with the preparation for regulatory audits and inspections. Support the development and maintenance of quality assurance systems and procedures. Collaborate with cross-functional teams to resolve quality issues and improve processes. Review and update Standard Operating Procedures (SOPs), batch records, and documentation. Train staff on GMP guidelines and company quality policies.
Read on to find out what you will need to succeed in this position, including skills, qualifications, and experience.
Responsibilities
Monitor compliance with GMP, FDA, and regulatory requirements throughout manufacturing. Conduct inspections, audits, and testing to ensure products meet quality standards. Review batch records, documentation, and processes for compliance with quality protocols. Investigate deviations, non-conformances, and customer complaints, implementing corrective actions. Assist with the preparation for regulatory audits and inspections. Support the development and maintenance of quality assurance systems and procedures. Collaborate with cross-functional teams to resolve quality issues and improve processes. Review and update Standard Operating Procedures (SOPs), batch records, and documentation. Train staff on GMP guidelines and company quality policies.
Requirements:
Bachelor's degree in Pharmaceutical Sciences, Life Sciences, Chemistry, or a related field. 2+ years of experience in Quality Assurance, preferably in the pharmaceutical or biotechnology industry. Strong understanding of GMP, FDA regulations, and industry standards. Experience with pharmaceutical manufacturing processes and quality control testing. Strong attention to detail and communication skills. Proficiency with Microsoft Office Suite; experience with quality management software is a plus. Seniority level
Seniority levelAssociate Employment type
Employment typeContract Job function
Job functionQuality Assurance IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Quality Assurance Specialist jobs in
Boston, MA . QA Specialist II, Validation, Contractor Cambridge, MA $67,151.00 - $79,460.00 2 weeks ago Boston, MA $71,453.20 - $102,351.00 1 month ago Canton, MA $70,000.00 - $85,000.00 1 day ago Lowell, MA $105,000.00 - $125,000.00 5 days ago Marlborough, MA $130,000.00 - $155,000.00 3 weeks ago Senior Manager, Global Pharmacovigilance (PV) Quality AssuranceQuality Assurance & Communications SpecialistAssociate Director, Quality Assurance GMP Training Management Bedford, MA $175,800 - $217,100 1 week ago Quality Control Aerospace Manufacturing (Multiple shifts)Quality Assurance Specialist, Cellular TherapyAssociate Director, Quality Assurance – Facilities Management Bedford, MA $179,400 - $221,700 5 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr