Planet Pharma ยท 7 hours ago
Quality Assurance Specialist
Holly Springs, NC
Full-time
Onsite
Mid, Senior Level
$26/hr - $36/hr
3+ years expPlanet Pharma is seeking a Quality Assurance Specialist to provide quality support and oversight of commissioning & qualification and process qualification. The role focuses on Computer System Validation and Automation support, requiring collaboration with various teams to ensure compliance and effective management of QA activities.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance, with an emphasis on Computer Systems Validation (CSV)
Work to be the QA partner on a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and QA oversight
Support DTI in the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solution
Effectively manage relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors
Provide QA support for managing DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements
Responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation
May include providing QA Oversite for Kneat protocols, Quality approval of ALM test scripts, approval of Service Now work requests, and QA approval of Maximo Work Orders
Provide quality guidance and support during execution of commissioning and qualification testing, reviewing, and approving changes and discrepancies, as required
Ensure that all activities & related documentation for facilities, equipment, materials, computer systems and processes comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies
Participate in meetings related to document planning, execution, and issue resolution
Escalate any compliance concerns or critical gaps to QA management
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role
Qualification
Required
Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Experience in quality support and oversight of commissioning & qualification and process qualification
Focus on Computer System Validation and Automation support
Ability to work alongside DTI (Digital, Technology and Innovation) and Automation
Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site
Experience with facilities/utilities, equipment/systems, computerized systems, process and validation maintenance
Emphasis on Computer Systems Validation (CSV)
Ability to manage relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors
Experience in reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation
Ability to provide quality guidance and support during execution of commissioning and qualification testing
Ensure compliance with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
Ability to provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies
Participation in meetings related to document planning, execution, and issue resolution
Ability to escalate any compliance concerns or critical gaps to QA management
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase