Lantheus
PET Supplier Quality Sr. Analyst
Lantheus, Billerica, Massachusetts, us, 01821
Summary of role
Supports quality and technical activities to assure Contract Manufacturing Organization (CMO) and PET Manufacturing Facilities exceed Lantheus' requirements for Pharmaceutical Products and Positron Emission Tomography (PET) Drug manufacturing.
Key Responsibilities/Essential Functions
Independently reviews and evaluates technical deviations, investigations, CAPAs, change controls, and OOS. Provides feedback to CMOs and documents associated records within the Lantheus internal Quality Management System (QMS).
Supporting process improvements of PET to assure compliance with regulatory, procedures, standards and contractual compliance.
Supports and performs PET site qualification audits and documentation to support regulatory filings.
Review and approve supplier corrective action plans and oversee plan execution.
Maintain current audit schedule and status in relevant system/tracker.
Collects and reviews documentation for the CMOs used in performing activities relevant to PET manufacturing and testing such as Master Batch Records, EM reports and others as applicable.
Provides feedback for the review of Master Batch Records and critical SOPs from the CMOs.
Reviews EM reports, Media Fills and BR based on procedures in place.
Provides technical support for FAR and recall evaluation/contents.
Participates in weekly/monthly/quarterly meetings for PET supply with CMOs.
Support inspection readiness and provide audit support, as required.
Build a strong working relationship with MT&D, R&D, Supply, and Regulatory to support a high performance culture.
Collaborate well with project team and work efficiently in a team environment. Communicate effectively with management, contractors, consultants and vendors.
Support and lead continuous improvement activities for the managed activities, as needed.
Actively demonstrate the Lantheus values of accountability, quality, efficiency, customer service, collaboration and safety.
Basic Qualifications
Bachelor's degree required in a related science discipline.
2+ years working in the pharmaceutical industry.
2+ years in a Quality role.
Must demonstrate thorough knowledge of conducting effective investigations.
Working knowledge with PET Good Manufacturing Practice guidance and FDA regulations regarding the manufacturing of PET drugs is preferred.
Aseptic processing experience preferred.
Excellent Documentation skills.
Excellent technical writing skills.
Knowledge and understanding of GCPs and GMPs.
Ability to work effectively with cross-disciplinary teams and with Suppliers.
Flexibility and Adaptability.
Experience in Sterile Manufacturing and CMO Management preferred.
Strong problem-solving skills, excellent communication skills both written and verbal.
Proficiency with Microsoft Office to include Word, Excel, PowerPoint, Adobe Acrobat, and SharePoint.
Demonstrated ability to work independently and in cross-functional teams.
Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.
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Supports quality and technical activities to assure Contract Manufacturing Organization (CMO) and PET Manufacturing Facilities exceed Lantheus' requirements for Pharmaceutical Products and Positron Emission Tomography (PET) Drug manufacturing.
Key Responsibilities/Essential Functions
Independently reviews and evaluates technical deviations, investigations, CAPAs, change controls, and OOS. Provides feedback to CMOs and documents associated records within the Lantheus internal Quality Management System (QMS).
Supporting process improvements of PET to assure compliance with regulatory, procedures, standards and contractual compliance.
Supports and performs PET site qualification audits and documentation to support regulatory filings.
Review and approve supplier corrective action plans and oversee plan execution.
Maintain current audit schedule and status in relevant system/tracker.
Collects and reviews documentation for the CMOs used in performing activities relevant to PET manufacturing and testing such as Master Batch Records, EM reports and others as applicable.
Provides feedback for the review of Master Batch Records and critical SOPs from the CMOs.
Reviews EM reports, Media Fills and BR based on procedures in place.
Provides technical support for FAR and recall evaluation/contents.
Participates in weekly/monthly/quarterly meetings for PET supply with CMOs.
Support inspection readiness and provide audit support, as required.
Build a strong working relationship with MT&D, R&D, Supply, and Regulatory to support a high performance culture.
Collaborate well with project team and work efficiently in a team environment. Communicate effectively with management, contractors, consultants and vendors.
Support and lead continuous improvement activities for the managed activities, as needed.
Actively demonstrate the Lantheus values of accountability, quality, efficiency, customer service, collaboration and safety.
Basic Qualifications
Bachelor's degree required in a related science discipline.
2+ years working in the pharmaceutical industry.
2+ years in a Quality role.
Must demonstrate thorough knowledge of conducting effective investigations.
Working knowledge with PET Good Manufacturing Practice guidance and FDA regulations regarding the manufacturing of PET drugs is preferred.
Aseptic processing experience preferred.
Excellent Documentation skills.
Excellent technical writing skills.
Knowledge and understanding of GCPs and GMPs.
Ability to work effectively with cross-disciplinary teams and with Suppliers.
Flexibility and Adaptability.
Experience in Sterile Manufacturing and CMO Management preferred.
Strong problem-solving skills, excellent communication skills both written and verbal.
Proficiency with Microsoft Office to include Word, Excel, PowerPoint, Adobe Acrobat, and SharePoint.
Demonstrated ability to work independently and in cross-functional teams.
Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at talentacquisition@lantheus.com.
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