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Quality Assurance Specialist

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Actalent

11d ago

  • Job
    Full-time
    Junior & Mid Level
  • Coral Springs

AI generated summary

  • You must review batch records, communicate effectively, ensure compliance with regulations, analyze test results, manage quality events, support audits, and drive quality improvements while following SOPs.
  • You will review batch records, documentation, and test results, communicate with teams, ensure compliance, support audits, track quality metrics, and participate in improvement initiatives.

Requirements

  • Review executed batch records and all related documentation for manufacturing activities in accordance with good documentation practices (GDP), product specifications, process parameters, and regulatory requirements.
  • Communicate effectively with cross-functional departments to ensure on-time delivery of corrections, QA review, and disposition responsibilities.
  • Compile and review all applicable documentation for batch review and release, keep track and oversee the status of batches to ensure all QA batch disposition deadlines are met.
  • Review analytical reports to ensure that products, materials, components, and intermediates meet company standards and regulatory requirements.
  • Review all test results generated in support of testing of raw materials, in-process, finished products, and stability samples, including but not limited to assays, chromatographic purity, content uniformity using HPLC/UPLC, particle size distribution, density, water determination, and other tests according to in-house monographs and USP and other compendia in a regulated laboratory environment.
  • Review environmental monitoring data, microbiology, and cleaning testing results.
  • Review quality events, incidents, and deviations related to manufacturing processes and laboratory testing, OOS, OOT, and OOE investigations.
  • Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices.
  • Provide the required support during regulatory and internal audits.
  • Keep track of data and records review indicators for internal quality metrics and annual product review.
  • Identify and participate in internal quality improvement initiatives, evaluate internal processes, suggest improvements, and create and revise relevant SOPs.
  • Documentation Control
  • GDP
  • Batch Record
  • Effective Communication
  • Attention to Detail
  • Problem Solving
  • Collaboration
  • Initiative

Responsibilities

  • Review executed batch records and all related documentation for manufacturing activities in accordance with good documentation practices (GDP), product specifications, process parameters, and regulatory requirements.
  • Communicate effectively with cross-functional departments to ensure on-time delivery of corrections, QA review, and disposition responsibilities.
  • Compile and review all applicable documentation for batch review and release, keep track and oversee the status of batches to ensure all QA batch disposition deadlines are met.
  • Review analytical reports to ensure that products, materials, components, and intermediates meet company standards and regulatory requirements.
  • Review all test results generated in support of testing of raw materials, in-process, finished products, and stability samples, including but not limited to assays, chromatographic purity, content uniformity using HPLC/UPLC, particle size distribution, density, water determination, and other tests according to in-house monographs and USP and other compendia in a regulated laboratory environment.
  • Review environmental monitoring data, microbiology, and cleaning testing results.
  • Review quality events, incidents, and deviations related to manufacturing processes and laboratory testing, OOS, OOT, and OOE investigations.
  • Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices.
  • Provide the required support during regulatory and internal audits.
  • Keep track of data and records review indicators for internal quality metrics and annual product review.
  • Identify and participate in internal quality improvement initiatives, evaluate internal processes, suggest improvements, and create and revise relevant SOPs.

FAQs

Is this position remote?

No, this is a fully on-site position in Coral Springs, Florida.

What is the duration of the contract for this position?

The contract duration for this position is 6 months.

What are the working hours for this role?

The hours for this role are 1x 2nd shift from 2pm to 10pm, and 1x 3rd shift from 10pm to 6am.

What kind of environment will I be working in?

You will be working in a lab environment that is FDA and GMP regulated, specifically in a clean room.

Is there room for growth and improvement within this position?

Yes, you will have opportunities to identify and participate in internal quality improvement initiatives and suggest process improvements.

What types of skills are important for this role?

Important hard skills include Documentation Control, Good Documentation Practices (GDP), and Batch Record management. Essential soft skills include Effective Communication, Attention to Detail, Problem Solving, Collaboration, and Initiative.

Will I be involved in internal audits?

Yes, you will provide the required support during regulatory and internal audits.

What types of documentation will I review in this position?

You will review executed batch records, analytical reports, environmental monitoring data, microbiology results, and documentation related to quality events and deviations.

How does Actalent approach diversity and inclusion?

Actalent emphasizes diversity and inclusion by hiring diverse talent, maintaining an inclusive environment, building a culture of care and engagement, and ensuring growth opportunities for all employees.

What should I do if I need a reasonable accommodation during the application process?

If you need a reasonable accommodation due to a disability, please email actalentaccommodation@actalentservices.com for options.

Actalent

An Engineering and Sciences Services Company | People to Possible

Human Resources
Industry
5001-10,000
Employees

Mission & Purpose

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent’s global footprint and flexible delivery models ensure access to specialized talent where and when you need it. We promote consultant engagement through professional development and provide experiences to ensure continuous learning. Our people are the difference. Our expertise spans capabilities in engineering including product and manufacturing, systems and software, construction management, environmental, architecture and civil; and power and utilities. We focus on sciences capabilities in laboratory sciences, healthcare, and clinical research. Actalent is an operating company of Allegis Group, the global leader in talent solutions.