Quality Assurance Senior Associate

1 week ago

VilleSavoye, Hauts-de-France, United States ApTask Full time

About the Company:

ApTask is a global leader in workforce solutions and talent acquisition services, dedicated to shaping the future of work.

We are an African American-owned and Veteran-certified company, offering 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.

Job Summary:

We are seeking a Quality Assurance Senior Associate to join our team. In this vital role, you will be responsible for PQA (Plant Quality Assurance) On the Floor in support of Manufacturing activities.

This position requires working directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.

Key Responsibilities:

  • Provide Quality Oversight: Ensure that operations products are manufactured, tested, stored, and distributed according to current applicable regulations.
  • Ensure Compliance: Ensure that facilities, equipment, materials, organization, processes, procedures, and products follow cGMP practices and other applicable regulations.
  • Document Management: Perform review and approval of cGMP processes, procedures, documents, and records. Review logbooks, batch records, attachments, work orders, and other GMP documentation.
  • Deviation Management: Ensure that deviations from established procedures are documented per procedures.
  • Data Integrity: Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
  • Risk Alerting: Alert management of quality, compliance, supply, and safety risks.
  • Training and Development: Complete required assigned training to permit execution of required tasks.
  • Clean Room Operations: Responsible for being in clean room space for majority of time on shift which includes gowning in and out of frocks and coveralls.
  • Collaboration: Communicating and collaborating with the PQA shift to ensure required tasks are completed.

Requirements:

  • Bachelor's Degree: Bachelor's degree in a relevant field and 2 years of Quality/Manufacturing work experience.
  • cGMP Experience: Experience working in a cGMP environment.
  • Decision Making: Experience with decision making.
  • Analytical Testing: Experience with analytical testing and/or general compendia testing.
  • GMP Documentation: Experience working with batch records and other GMP documentation.
  • Data Integrity Knowledge: Knowledge of data integrity requirements.
  • Microsoft Office Skills: Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams).
  • Communication Skills: Excellent written and verbal communication skills.
  • Ambiguity Navigation: Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment.

Compensation and Benefits:

The estimated salary for this role is $34-$35/Hr. We offer non-benefitted positions, with subsidized insurance coverage to our employees.

About Us:

At ApTask, we empower organizations to thrive while fostering a diverse and inclusive work environment.

We connect businesses with top-tier professionals, optimize workforce performance, and drive success across diverse industries.

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