Infotree Global Solutions ยท 5 hours ago
Senior Quality Assurance Associate (GMP/Floor)
Holly Springs, NC
Contract
Onsite
Mid, Senior Level
4+ years expInfotree Global Solutions is seeking a Senior Quality Assurance Associate to work directly with plant manufacturing and support groups for ongoing bulk drug substance manufacturing and new product introduction. The role involves ensuring adherence to GMP quality requirements while providing guidance and oversight for manufacturing processes and quality compliance.
Human ResourcesStaffing AgencyTechnical Support
Hiring Manager
Abhey Abrol
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
Manufacturing and PQA background
Previous work on GNP Facilities
PQA or Mfg preferably Drug Substance Experience
Previous work with Batch records/Deviations/Qa Oversight
Preferred
B.S. degree
Company
Infotree Global Solutions
Infotree Global Solutions is a talent management company specializing in staffing and payroll solutions.
1001-5000 employees
H1B Sponsorship
Infotree Global Solutions 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
2025 (8)
2024 (9)
2023 (11)
2022 (17)
2021 (16)
2020 (19)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Kingswood Capital Management
2025-02-20Private Equity
Leadership Team
Matt Milano
Chief Executive Officer
Klaus Geiser
Chief Financial Officer
Recent News
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