Planet Pharma · 9 hours ago
Quality Assurance Specialist
Holly Springs, NC
Contract
Onsite
Entry, Mid Level
$34/hr - $35/hrPlanet Pharma is a company focused on providing quality support in the pharmaceutical industry. The QA Specialist will oversee commissioning and qualification activities, ensuring compliance with regulations and collaborating across teams to meet project timelines.
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
Perform quality review of documents to support facility commissioning and qualification, according to project timelines
Commissioning / Qualification Protocols
Performance Qualification Protocols (PQ)
Review and Approval of protocol discrepancies
Review of Final Reports and Summary Documents
Provide quality 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, and processes comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
Ensure documents comply with procedures, regulatory expectations (e.g., FDA, EMA), and Good Documentation Practices (GDP)
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
Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site
Perform quality review of documents to support facility commissioning and qualification, according to project timelines
Commissioning / Qualification Protocols
Performance Qualification Protocols (PQ)
Review and Approval of protocol discrepancies
Review of Final Reports and Summary Documents
Provide quality 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, and processes comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
Ensure documents comply with procedures, regulatory expectations (e.g., FDA, EMA), and Good Documentation Practices (GDP)
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
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
Founded in 2009
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