Specialist, QA Validation
2 weeks ago
Pay $76-$81 per hourOn-site Role 1 year extendable contractMedical, Dental, Vision, 401kThe Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation.Responsibilities and Accountabilities:• Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance.• Provide QA review and approval for commissioning/qualification/validation documents.• Provide QA review and approval of qualification and validation deviations and discrepancies and support investigation and corrective actions.• Author, review and approved controlled documents for the Quality organization including SOPs, specifications, protocols, and reports.Qualifications:• B.S. degree in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study and 3-5+ years of experience or M.S. degree and 1-3+ years of experience in a QA function in a biologics manufacturing facility• Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities.• Strong understanding of FDA, EMA, local regulations and guidelines, ICH guidelines, and industry best practices.• Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects• Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others• Excellent problem-solving skills and experience with root cause investigations and CAPA determination• Off hours coverage and flexibility may be required
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QA Validation Specialist
2 weeks ago
Sanford, United States SPECTRAFORCE Full timePosition Title: QA Validation SpecialistWork Location: Sanford, NC 27330Assignment Duration: 11 monthsWork Schedule: 8 AM - 4:30 PMWork Arrangement: 100% onsitePosition Summary: The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP...
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Specialist, QA Validation
3 weeks ago
Sanford, United States Planet Pharma Full timePay $76-$81 per hourOn-site Role 1 year extendable contractMedical, Dental, Vision, 401kThe Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, Quality...
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Specialist, QA Validation
3 weeks ago
Sanford, United States Planet Pharma Full timePay $76-$81 per hourOn-site Role 1 year extendable contractMedical, Dental, Vision, 401kThe Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing, Quality...
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Specialist, QA Validation
2 weeks ago
Sanford, NC, United States Planet Pharma Full timePay $76-$81 per hour On-site Role 1 year extendable contract Medical, Dental, Vision, 401k The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing,...
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Specialist, QA Validation
2 weeks ago
Sanford, NC, United States Planet Pharma Full timePay $76-$81 per hour On-site Role 1 year extendable contract Medical, Dental, Vision, 401k The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with Validation, Engineering, Manufacturing,...
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Specialist, QA Validation
1 week ago
Sanford, NC, United States Planet Pharma Full timePay $76-$81 per hour On-site Role 1 year extendable contract Medical, Dental, Vision, 401k Please read the following job description thoroughly to ensure you are the right fit for this role before applying. The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records...
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QA Validation Specialist
2 weeks ago
Sanford, NC, United States SPECTRAFORCE Full timePosition Title: QA Validation Specialist Work Location: Sanford, NC 27330 most team works 1 day remote) Position Summary: The Specialist, QA Validation will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This position works closely with...
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Validation Engineer
5 days ago
Sanford, NC, United States PharmEng Technology Full timeAbout the job Validation Engineer Job Title: Validation Engineer Lyophilization Specialist Location: Sanford, NC (Long-Term Contract) About the Role:We are seeking an experienced Validation Engineer specializing in lyophilization processes and equipment. The ideal candidate will lead validation activities, ensuring compliance with regulatory standards while...
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Validation Engineer
7 days ago
Sanford, NC, United States PharmEng Technology Full timeAbout the job Validation Engineer Job Title: Validation Engineer Lyophilization Specialist Location: Sanford, NC (Long-Term Contract) About the Role:We are seeking an experienced Validation Engineer specializing in lyophilization processes and equipment. The ideal candidate will lead validation activities, ensuring compliance with regulatory standards while...
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Specialist, Quality Assurance for QC
1 week ago
Sanford, United States Astellas Full timeSpecialist, Quality Assurance for QC Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a...