Planet Pharma · 3 days ago
Senior Quality Assurance Associate
West Greenwich, RI
Contract
Onsite
Mid, Senior Level
$31/hr - $32/hr
2+ years expPlanet Pharma is seeking a Senior Quality Assurance Associate to provide on-the-floor quality oversight for various operations. The role involves ensuring compliance with cGMP and regulatory requirements while collaborating with cross-functional teams.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Provide quality oversight for F&E, IQA Warehouse areas (including Incoming Inspections and the Raw Material Sampling Lab), and Process Development Laboratories
Ensure facilities, equipment, materials, processes, and products comply with cGMP standards and other applicable regulatory requirements
Review and approve work orders and job plans within Maximo
Review logbooks (paper-based and electronic), particle-generating forms, pest control sighting forms, and periodic pest control (monthly/quarterly) reports, RT reports, and other GMP documentation
Review and approve Manufacturing Execution System (MES) records, including EBRs and ESPs
Handling of reject materials
Review/Approve Delta V Audit Trail entries
Ensure that any deviations from established procedures are properly documented according to approved processes
Communicate and collaborate effectively across departments (PQA, PD, IQA, F&E, and Manufacturing) to ensure completion of assigned tasks
Complete required training assignments to maintain compliance and readiness for task execution
Proactively identify and escalate quality, compliance, or safety risks to management
Maintain a presence in cleanroom areas (~25% of shift time), including proper gowning and adherence to aseptic practices
Qualification
Required
Provide quality oversight for F&E, IQA Warehouse areas (including Incoming Inspections and the Raw Material Sampling Lab), and Process Development Laboratories
Ensure facilities, equipment, materials, processes, and products comply with cGMP standards and other applicable regulatory requirements
Review and approve work orders and job plans within Maximo
Review logbooks (paper-based and electronic), particle-generating forms, pest control sighting forms, and periodic pest control (monthly/quarterly) reports, RT reports, and other GMP documentation
Review and approve Manufacturing Execution System (MES) records, including EBRs and ESPs
Handling of reject materials
Review/Approve Delta V Audit Trail entries
Ensure that any deviations from established procedures are properly documented according to approved processes
Communicate and collaborate effectively across departments (PQA, PD, IQA, F&E, and Manufacturing) to ensure completion of assigned tasks
Complete required training assignments to maintain compliance and readiness for task execution
Proactively identify and escalate quality, compliance, or safety risks to management
Maintain a presence in cleanroom areas (~25% of shift time), including proper gowning and adherence to aseptic practices
Preferred
Bachelor's Degree in a relevant field (e.g. Life Sciences)
Minimum of 2 year of experience in Quality or Manufacturing, with exposure to F&E-related activities
Strong understanding of cGMP principles and regulatory expectations
Demonstrated experience utilizing enterprise systems such as Maximo, OEFM, MES, and Veeva Vault (CDOCS/DQMS) to support quality oversight, documentation management, and manufacturing execution processes
Proficient in Microsoft Office applications, including Outlook, Word, Excel, PowerPoint, and Teams
Excellent written and verbal communication skills
Experience collaborating within and across functional areas, with a strong focus on customer service and partnership
Demonstrated ability to make sound decisions in a dynamic, fast-paced environment
Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment
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