Responsibilities:
Perform batch record reviews for accuracy, completeness, and compliance with Good Manufacturing Practices (GMP).
Conduct quality inspections and audits of incoming materials, in-process operations, and final products.
Support the documentation and investigation of deviations, non-conformances, CAPAs, and change controls.
Assist in the maintenance and archiving of QA documentation and controlled records.
Monitor and ensure compliance with internal SOPs, regulatory guidelines (FDA, EMA), and industry best practices.
Participate in internal audits and prepare for external inspections by regulatory authorities and clients.
Collaborate with manufacturing, QC, and engineering teams to ensure quality objectives are met.
Support training initiatives and ensure QA-related training records are up-to-date.
Contribute to the continuous improvement of QA processes and systems.
Working hours: 8:00 AM - 5:00 PM
Skills:
Experience with quality management systems (QMS), electronic documentation systems, and LIMS.
Prior involvement with regulatory inspections or client audits.
Familiarity with viral vector or cell and gene therapy manufacturing.
Education:
High School
Experience:
1-4 years
Qualifications:
Minimum of 1???2 years of experience in a GMP-regulated environment, preferably in pharmaceuticals, biotechnology, or biologics manufacturing.
Working knowledge of cGMP, FDA regulations (21 CFR Parts 210, 211), and ICH guidelines.
Excellent attention to detail and strong documentation skills.
Proficient in Microsoft Office Suite (Word, Excel, Outlook).
Strong verbal and written communication skills.
Ability to work independently and collaboratively in a fast-paced, regulated environment.
Apply today!
Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact Callcenter@spherion.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
Responsibilities:
Perform batch record reviews for accuracy, completeness, and compliance with Good Manufacturing Practices (GMP).
Conduct quality inspections and audits of incoming materials, in-process operations, and final products.
Support the documentation and investigation of deviations, non-conformances, CAPAs, and change controls.
Assist in the maintenance and archiving of QA documentation and controlled records.
Monitor and ensure compliance with internal SOPs, regulatory guidelines (FDA, EMA), and industry best practices.
Participate in internal audits and prepare for external inspections by regulatory authorities and clients.
Collaborate with manufacturing, QC, and engineering teams to ensure quality objectives are met.
Support training initiatives and ensure QA-related training records are up-to-date. ... Contribute to the continuous improvement of QA processes and systems.
Working hours: 8:00 AM - 5:00 PM
Skills:
Experience with quality management systems (QMS), electronic documentation systems, and LIMS.
Prior involvement with regulatory inspections or client audits.
Familiarity with viral vector or cell and gene therapy manufacturing.
Education:
High School
Experience:
1-4 years
Qualifications:
Minimum of 1???2 years of experience in a GMP-regulated environment, preferably in pharmaceuticals, biotechnology, or biologics manufacturing.
Working knowledge of cGMP, FDA regulations (21 CFR Parts 210, 211), and ICH guidelines.
Excellent attention to detail and strong documentation skills.
Proficient in Microsoft Office Suite (Word, Excel, Outlook).
Strong verbal and written communication skills.
Ability to work independently and collaboratively in a fast-paced, regulated environment.
Apply today!
Spherion has helped thousands of people just like you find work happiness! Our experienced staff will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temp-to-perm or direct hire opportunities, no one works harder for you than Spherion.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Spherion, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact Callcenter@spherion.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Spherion offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
Perform batch record reviews for accuracy, completeness, and compliance with Good Manufacturing Practices (GMP).Conduct quality inspections and audits of incoming materials, in-process operations, and final products.Support the documentation and investigation of deviations, non-conformances, CAPAs, and change controls.Assist in the maintenance and archiving of QA documentation and controlled records.Monitor and ensure compliance with internal SOPs, regulatory guidelines (FDA, EMA), and industry best practices.Participate in internal audits and prepare for external inspections by regulatory authorities and clients.Collaborate with manufacturing, QC, and engineering teams to ensure quality objectives are met.Support training initiatives and ensure QA-related training records are up-to-date.Contribute to the continuous improvement of QA processes and systems.
experience1-4 years
skillsExperience with quality management systems (QMS), electronic documentation systems, and LIMS.Prior involvement with regulatory inspections or client audits.Familiarity with viral vector or cell and gene therapy manufacturing.
qualificationsMinimum of 1???2 years of experience in a GMP-regulated environment, preferably in pharmaceuticals, biotechnology, or biologics manufacturing.Working knowledge of cGMP, FDA regulations (21 CFR Parts 210, 211), and ICH guidelines.Excellent attention to detail and strong documentation skills.Proficient in Microsoft Office Suite (Word, Excel, Outlook).Strong verbal and written communication skills.Ability to work independently and collaboratively in a fast-paced, regulated environment.
educationHigh School
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