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QA Shop Floor Specialist (6AM-6PM)

Posted 12 days ago

  • Expiry Date: 15 December 2022
  • Referral: 219859@accuick.com

Job Description:

Responsibilities:

  • Build and maintain relationships with Manufacturing Operations, Quality Control, Manufacturing Science & Technology, and other departments to effectively accomplish responsibilities, make improvements and resolve issues.

  • Perform QA shop floor activities, focused on Manufacturing Operations.

  • Ensure compliance with applicable procedures and production requirements.

  •  Perform real-time review of manufacturing records. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

  • 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.

  • Develops and revise procedures.

Knowledge & Skills:

  • 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.

  • Contributes to goals within the workgroup.

  • Ability to direct quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

  • Possess sound knowledge of FDA-regulated cGMP Quality Manufacturing operations and processes and global cGMP requirements.

  • Must be skilled in planning and organizing, decision-making, and building relationships.

  • Knowledge of quality processes, including material disposition, material storage, and handling requirements, change control, product complaints, deviations, investigations, and CAPA management

  • Able to recognize conflict and notify management with proposed recommendations for resolution.

  • 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 issue.

  • 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.

  • Excellent verbal and written communication skills.

Basic Requirements:

  • High School Diploma/GED

  • At least six months of experience working in a GMP Aseptic manufacturing environment

  • Experience in FDA-regulated cGMP Quality Manufacturing operations and processes.

  • Available for weekend and off-shift hours

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Contact:

Full Name: Akash Mehra

Email ID: akashm@askconsulting.com

Phone: 908-224-9613