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QA Shop Floor Specialist

Posted 28 days ago

  • Expiry Date: 06 July 2022
  • Referral: 209595@accuick.com

Job Description:

  • The QA Shop Floor Specialist is responsible for quality activities supporting Manufacturing Operations in accordance with client policies, standards, procedures, and Global cGMP.

  • Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues.

  • ***12 hours shift with split week including one weekend day.

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities:

  • Must have sound knowledge and experience in FDA regulated cGMP Quality Manufacturing operations and processes.

  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.

  • Must possess an independent mindset.

  • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.

  • Work is self-directed.

  • Confident in making decisions for non-routine issues.

  • Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.

  • Develops procedures.

  • Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.

  • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.

  • Must be action-oriented and customer-focused 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 work group.

  • Able to recognize conflict and notify management with proposed 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.

  • Excellent verbal and written communication skills.

DUTIES AND 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.

  • Ensure manufacturing compliance with applicable procedures and batch records.

  • Perform real time review of manufacturing batch records.

  • Review manufacturing shop floor documentation.

  • Issue production batch records and product labels to Operations.

  • 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.

  • Must be able to work in the cleanroom environment for 6-hour time periods.

  • Must be available for weekend and off-shift hours.

  • Must be flexible for shift hour changes to support manufacturing.

EDUCATION AND EXPERIENCE:

  • Minimum high school diploma required, with equivalent experience. Bachelor's degree with 4+ years of relevant work experience preferred.

  • Aseptic experience preferred, but not required.

WORKING CONDITIONS (US Only): 

  • Work is performed in a combination of manufacturing cleanroom and office environments, with standard office equipment available and used.

  • Work is generally performed in a cleanroom environment, generally seated but may require standing and walking for up to 50% of the time.

  • Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc. 

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.