Planet Pharma
Job Description
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Job Summary:
The
Sr. Specialist, Quality Assurance
is an intermediate level position with hands-on QA experience. Under moderate supervision, the individual will be working in the Quality Systems team for providing quality oversight of the lifecycle management of GxP Facilities, Utilities, Equipment, Analytical Instruments, and Computerized Systems. The individual will also provide support in maintaining the company's Data Integrity Program. This role will be interacting with cross-functional groups such as Quality Control, Manufacturing, Facilities, IT, Supply Chain, and Regulatory Affairs.
Reporting to:
Sr. Manager, Quality Assurance
Location
Newark, CA
Responsibilities/Essential Duties: Perform a wide variety of quality assurance activities to ensure compliance with Revance procedures, applicable US and international regulatory requirements for biologic drug substances and drug products. Coordinate and track closure of quality records such as change controls, deviations, CAPAs, quality investigations, etc. Provide quality oversight for Facilities/Utility System/Equipment (FUSE) Qualification, Analytical Instrument Qualification (AIQ) and Computerized Systems Validation/Assurance(CSV/CSA) and applies risk-based methodology to validation/qualification efforts in accordance with current regulatory requirements and industry guidance. Provide quality oversight for System and Equipment implementation activities related to Analytical Development method project. Provides quality oversight of steady state activities and quality records (deviations, CAPAs, and changes controls) for GxP Facilities, Utilities, Equipment, Analytical Instruments, and Computerized Systems. Drive data integrity awareness and maintain the Data Integrity Program to ensure compliance and reliability across the data lifecycle for GxP Operations. Support continuous improvement of quality systems by authoring new or revising existing department procedures and/or forms. Other duties as assigned. Skills: Must be proficient in Microsoft Office applications
Education: Minimum BS degree
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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Job Summary:
The
Sr. Specialist, Quality Assurance
is an intermediate level position with hands-on QA experience. Under moderate supervision, the individual will be working in the Quality Systems team for providing quality oversight of the lifecycle management of GxP Facilities, Utilities, Equipment, Analytical Instruments, and Computerized Systems. The individual will also provide support in maintaining the company's Data Integrity Program. This role will be interacting with cross-functional groups such as Quality Control, Manufacturing, Facilities, IT, Supply Chain, and Regulatory Affairs.
Reporting to:
Sr. Manager, Quality Assurance
Location
Newark, CA
Responsibilities/Essential Duties: Perform a wide variety of quality assurance activities to ensure compliance with Revance procedures, applicable US and international regulatory requirements for biologic drug substances and drug products. Coordinate and track closure of quality records such as change controls, deviations, CAPAs, quality investigations, etc. Provide quality oversight for Facilities/Utility System/Equipment (FUSE) Qualification, Analytical Instrument Qualification (AIQ) and Computerized Systems Validation/Assurance(CSV/CSA) and applies risk-based methodology to validation/qualification efforts in accordance with current regulatory requirements and industry guidance. Provide quality oversight for System and Equipment implementation activities related to Analytical Development method project. Provides quality oversight of steady state activities and quality records (deviations, CAPAs, and changes controls) for GxP Facilities, Utilities, Equipment, Analytical Instruments, and Computerized Systems. Drive data integrity awareness and maintain the Data Integrity Program to ensure compliance and reliability across the data lifecycle for GxP Operations. Support continuous improvement of quality systems by authoring new or revising existing department procedures and/or forms. Other duties as assigned. Skills: Must be proficient in Microsoft Office applications
Education: Minimum BS degree
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.