Katalyst CRO
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Quality Assurance
role at
Katalyst CRO .
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Job Description The Quality Assurance professional will perform audits and inspections of records, reports, and processes to ensure compliance with regulatory requirements, international standards, and company policies. The role involves reviewing documentation, identifying deviations, supporting client site visits, and assisting with regulatory training and compliance projects.
Responsibilities
Conduct audits and inspections to verify compliance with regulations, SOPs, and company policies.
Review and verify accuracy and completeness of SOPs, protocols, batch records, and reports.
Identify, document, and report deviations from established processes and standards.
Participate in developing corrective and preventive actions to address audit findings.
Maintain accurate written records of all audits, inspections, and quality activities.
Support client site visits and regulatory inspections.
Assist in providing regulatory training and in scheduling QA audits and inspections.
Inspect materials and supplies for compliance with specifications.
Requirements
Bachelor's degree in Life Sciences or a related field.
12 years of experience in a QA role.
Strong attention to detail and communication skills (verbal and written).
Proficiency in Microsoft Office (Word, Excel, Access).
Ability to interpret regulations and apply critical thinking skills.
Seniority level
Entry level
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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Reading, PA $100,800.00–$140,000.00 1 month ago.
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Quality Assurance
role at
Katalyst CRO .
2 days ago – Be among the first 25 applicants.
Get AI-powered advice on this job and more exclusive features.
Job Description The Quality Assurance professional will perform audits and inspections of records, reports, and processes to ensure compliance with regulatory requirements, international standards, and company policies. The role involves reviewing documentation, identifying deviations, supporting client site visits, and assisting with regulatory training and compliance projects.
Responsibilities
Conduct audits and inspections to verify compliance with regulations, SOPs, and company policies.
Review and verify accuracy and completeness of SOPs, protocols, batch records, and reports.
Identify, document, and report deviations from established processes and standards.
Participate in developing corrective and preventive actions to address audit findings.
Maintain accurate written records of all audits, inspections, and quality activities.
Support client site visits and regulatory inspections.
Assist in providing regulatory training and in scheduling QA audits and inspections.
Inspect materials and supplies for compliance with specifications.
Requirements
Bachelor's degree in Life Sciences or a related field.
12 years of experience in a QA role.
Strong attention to detail and communication skills (verbal and written).
Proficiency in Microsoft Office (Word, Excel, Access).
Ability to interpret regulations and apply critical thinking skills.
Seniority level
Entry level
Employment type
Contract
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Katalyst CRO by 2x.
Sign in to set job alerts for “Quality Assurance Specialist” roles.
Reading, PA $100,800.00–$140,000.00 1 month 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