What are the responsibilities and job description for the Associate, QA Frontline position at BioSpace?
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
DutiesAlternate Weds, Thursday - Saturday 0600-1900 -Provide on-the-floor QA oversight and support to manufacturing operations -Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations -Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations -Represent QA in support of deviations including active participation in Root Cause Analysis (RCA) -Provide cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel-Provide QA support including authoring, review, and approval of documents in Quality Management Systems in accordance with BioMarin policies -Perform area walkthroughs -Perform other duties and projects as assigned by management Please note that while this role primarily involves night and weekend shift hours, there may be occasions where the need for flexibility is required, as shift hours can vary depending on operational demands.
Skills-Prior batch record execution or review experience -Prior experience in investigation, change control, other Quality Management Systems (QMS) -Working knowledge of cGMPs -Excellent written and verbal communication and interpersonal skills -Must display strong analytical and problem-solving skills -Manufacturing and Manufacturing Sciences experience preferred EducationB.S. in scientific discipline or equivalent work experience.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
DutiesAlternate Weds, Thursday - Saturday 0600-1900 -Provide on-the-floor QA oversight and support to manufacturing operations -Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations -Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations -Represent QA in support of deviations including active participation in Root Cause Analysis (RCA) -Provide cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel-Provide QA support including authoring, review, and approval of documents in Quality Management Systems in accordance with BioMarin policies -Perform area walkthroughs -Perform other duties and projects as assigned by management Please note that while this role primarily involves night and weekend shift hours, there may be occasions where the need for flexibility is required, as shift hours can vary depending on operational demands.
Skills-Prior batch record execution or review experience -Prior experience in investigation, change control, other Quality Management Systems (QMS) -Working knowledge of cGMPs -Excellent written and verbal communication and interpersonal skills -Must display strong analytical and problem-solving skills -Manufacturing and Manufacturing Sciences experience preferred EducationB.S. in scientific discipline or equivalent work experience.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.