Planet Pharma ยท 4 days ago
Senior Quality Assurance Associate
Holly Springs, NC
Full-time
Onsite
Senior Level
$23/hr - $33/hrPlanet Pharma is committed to creating an inclusive environment for all employees, and they are seeking a Senior Quality Assurance Associate. The role involves providing quality oversight and ensuring compliance with Good Manufacturing Practices in the manufacturing and support processes.
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
Experience in Quality Assurance within a manufacturing environment
Knowledge of Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
Ability to provide quality oversight and ensure compliance with regulations
Experience in driving closure/completion of cGMP processes, procedures, documents, and records
Strong analytical skills to oversee on-the-floor analytical testing
Ability to assess changes that could impact product quality
Experience in investigating and documenting deviations from established procedures
Strong communication skills to alert senior management of quality, compliance, supply, and safety risks
Project management skills to lead efforts and develop strategies for system implementation
Ability to identify and implement continuous improvement opportunities
Experience in supporting and representing Quality Assurance during audits and inspections
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