Quality Assurance Senior Specialist

14 hours ago

West Greenwich, United States ApTask Full time
About Client:
The client is one of the world's largest independent biotechnology companies, focusing on the discovery, development, and manufacturing of innovative human therapeutics. The company's areas of expertise include oncology, hematology, cardiovascular disease, inflammation, bone health, and neuroscience.
It has developed a wide range of biologic medicines, including biotechnology drugs, therapeutic antibodies, and other innovative therapies. The company collaborates with academic institutions, biotechnology partners, and other organizations to advance its research efforts.

Rate Range: $35-$40/Hr

Job Description:
  • Responsibilities: Primary focus is the support and oversight of Client's Quality Management Systems ensuring key requirements and initiatives are implemented, maintained and reviewed in accordance with cGMP regulations.
  • Additional detail responsibilities, accountabilities or decision authorities are defined in procedures to execute assigned task for the role and deployed through assignment of procedure training in the Learning Management System.
Responsibilities could include:
  • May be responsible for leading and directing the Quality functions for assigned plant(s) or functional area(s)
  • Responsible for providing Quality oversight to ensure that Client's systems are executed, according to current Good Manufacturing Practices (cGMP) and other applicable regulations
  • Ensures that Quality Management Systems comply with cGMP practices and other applicable regulations
  • Provide support for Global Process Owners executing key quality systems processes
  • Ensures the Quality unit provides review, approval and tracking of cGMP processes, procedures, assays, documents and records, including nonconformances, CAPAs, change control records and validations. May execute these tasks
  • Supports Continual Improvement initiatives, programs and projects
  • Ensures that changes that could potentially impact product quality are assessed according to procedures
  • Ensures that deviations from established procedures are investigated and documented per procedures
  • Collect and analyze Key Process Indicator (KPI) data to assessing process performance and areas of improvement
  • Alerts senior management of significant quality, compliance, supply and safety risks


Non-benefitted (other than those mandated under state or federal law).Please note that this position does not include paid time off benefits. ApTask offers subsidized insurance coverage to our employees.

About ApTask:
ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-certified company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management. With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development. As a member of the ApTask team, you will have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success across diverse industries. Join us at ApTask and be part of our mission to empower organizations to thrive while fostering a diverse and inclusive work environment.

Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.

Candidate Data Collection Disclaimer:
At ApTask, we prioritize safeguarding your privacy. As part of our recruitment process, certain Personally Identifiable Information (PII) may be requested by our clients for verification and application purposes. Rest assured, we strictly adhere to confidentiality standards and comply with all relevant data protection laws. Please note that we only collect the necessary information as specified by each client and do not request sensitive details during the initial stages of recruitment.

If you have any concerns or queries about your personal information, please feel free to contact our compliance team at businessexcellence@aptask.com

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