Field Specialist QA Operations

ACS group has an immediate need for a "Field Specialist QA Operations" with experience in the Pharmaceutical Industry. This is a 06 - months contract opportunity and is at Devens, Massachusetts. Our client is a leading pharmaceutical company.

Please review the job description below:

Top Skills:

  • Quality Assurance.
  • FDA regulated cGMP warehousing, Quality, and compliance environments.
  • High School Degree required.

Job Description:

OB RESPONSIBILITIES
* Perform QA shop floor activities.
* Ensure manufacturing compliance with applicable procedures and batch records.
* Perform real time review of manufacturing batch records.
* Review manufacturing shop floor documentation.
* Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
* Must be skilled in planning and organizing, decision-making, and building relationships.
* Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
* Able to effectively multi-task.
* Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles.
* Must be skilled in planning and organizing, decision-making, and building relationships.
* Knowledge of quality processes, change control, product complaints, deviations, investigations, and CAPA management.

QUALIFICATIONS AND EDUCATION REQUIREMENTS
* High School Degree required
* Relevant college or university degree preferred.
* Minimum 2 years relevant work experience, with experience in a Quality Assurance role.
* Equivalent combination of education and experience acceptable.
* Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
* Understands continuous improvement and improves efficiency and productivity within the group or project.
* Builds relationships internally within and with cross functional teams.
* Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.
* Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
* Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
* Able to recognize conflict and notify management with proposed recommendations for resolution.
* Must possess an independent mindset. Work is self-directed.
* Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
* Confident in making decisions for non-routine issues.
* Develops and revises procedures.
* Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
* Able to prepare written communications and communicate problems to management with clarity and accuracy.
* Able to effectively multi-task.
* Knowledge of US and global cGMP requirements..

Thanks, and regards,

Chandrakriti Maisnam

Team Recruitment

P: (+1) 770-255-7927


ABOUT ACS Solutions.

ACS Solutions is a global provider of information technology solutions, talent solutions and workforce management services. Our Industry vertical based domain expertise, passion for innovation, combined with the power of technologies in cognitive sciences, cloud computing, data sciences, product engineering, robotic process automation, machine learning, and block chain, helps clients envision, build and run their businesses more efficiently. Headquartered in the US, ACS Solutions has grown to over $1.2 BN.

ACS Solutions is a Certified MBE by the Georgia National Minority Supplier Development Council.

ACS solutions has multiple subsidiaries, each focused on the unique area of business:

  • Analysts international Corporation (Staff Augmentation Services)
  • The Ascent Services Group Inc. (Life Sciences Talent Solutions)
  • HireGenics, (Payrolling, IC Compliance, & MSP Services)
  • DATA Inc. (Information Technology- staffing)

Recent Awards and Recognitions:

  • 6th largest IT staffing firm in the US. (Staffing Industry Analysts (SIA) 2019)
  • Largest Minority IT Staffing Firm in the US. (SIA 2019)
  • ClearlyRated® 2020 Best of Staffing award winner for providing remarkable service quality to our clients. This is our ninth consecutive win.

IT and Industry certifications:

  • Microsoft Gold Partner: Application Development, Cloud Platform, Data Analytics, Data Center, DevOps, Data Platform
  • AWS Managed Services Partner
  • Google Cloud Partner
  • ISO 27001:2013 Certified for Data Security
  • ISTQB Gold Partner
  • ISMS (ISO 27001:2017)
  • SOC2 Type II Compliant
Company
Analysts
Posted
09/11/2021
Type
Full time
Location
Acton, MA 01720, US