PSG Global Solutions Careers
Quality Manager V
PSG Global Solutions Careers, Swiftwater, Pennsylvania, United States, 18370
Apply now and our proprietary system will quickly have you in front of a live recruiter.The OpportunityDescriptionWe're looking for a
Quality Manager V , working in
Pharmaceuticals and Medical Products
industry in
Swiftwater, Pennsylvania, 18370, United States .
Participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance and/or Drug Product Vaccines.Review and approve validation related studies for assigned areas. These assigned areas would include validation life cycle activities such as Validation Planning, Biotech Process.Validation, Equipment and Facility Qualification and Validation Risk Management.Signatory responsibilities for validation/qualification documents within assigned areas.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
5+ years' experience in a GMP regulated environment working on validation projects associated with biotech processes and equipmentWorking knowledge of cGMPs and regulatory requirementsExperience with validation of biotech manufacturing processes (i.e. viral antigen or formulation production) and knowledge of current FDA regulations and industry guidance related to validation processesKnowledge of vaccines/biologics products and associated technologiesRequires strong Commissioning and Qualification backgroundAbility to work on cross functional project teamsExperience with Quality Systems including: SAP, Quality eDoc, LabWare, TrackWise and MS OfficeStrength in several LEAD Competencies - Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions
What Do You Think?Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
Quality Manager V , working in
Pharmaceuticals and Medical Products
industry in
Swiftwater, Pennsylvania, 18370, United States .
Participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance and/or Drug Product Vaccines.Review and approve validation related studies for assigned areas. These assigned areas would include validation life cycle activities such as Validation Planning, Biotech Process.Validation, Equipment and Facility Qualification and Validation Risk Management.Signatory responsibilities for validation/qualification documents within assigned areas.
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
5+ years' experience in a GMP regulated environment working on validation projects associated with biotech processes and equipmentWorking knowledge of cGMPs and regulatory requirementsExperience with validation of biotech manufacturing processes (i.e. viral antigen or formulation production) and knowledge of current FDA regulations and industry guidance related to validation processesKnowledge of vaccines/biologics products and associated technologiesRequires strong Commissioning and Qualification backgroundAbility to work on cross functional project teamsExperience with Quality Systems including: SAP, Quality eDoc, LabWare, TrackWise and MS OfficeStrength in several LEAD Competencies - Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions
What Do You Think?Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?