Planet Pharma ยท 11 hours ago
Senior Quality Assurance Associate
Holly Springs, NC
Full-time
Onsite
Mid, Senior Level
$31/hr - $32/hr
4+ years expPlanet Pharma is seeking a Senior Quality Assurance Associate to support Manufacturing and Plant Quality Assurance operations. The role involves providing ongoing quality oversight to ensure adherence to GMP quality requirements and facilitating real-time decision making in a manufacturing environment.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls
Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s
Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements
Oversee and provide guidance during on-the-floor analytical testing
Ensure that changes that could potentially impact product quality are assessed according to procedures
Ensure that deviations from established procedures are investigated and documented per procedures
Alert senior management of quality, compliance, supply and safety risks
Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation
Identification and implementation of continuous improvement opportunities within our processes and systems
Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections
Qualification
Required
High school/GED + 4 years work experience or Associate + 2 years work experience or Bachelor + 6 months work experience or Masters Degree
Experience supporting Manufacturing and Plant Quality Assurance (PQA) operations
Previous work with Batch records/Deviations/QA Oversight
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