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QA Shop Floor Specialist

Posted 6 days ago

  • Expiry Date: 22 October 2022
  • Referral: 216457@accuick.com

Job Description:

REQUIRED COMPETENCIES:  

  • 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 them.

  • 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 workgroup. 

  • 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.

  • A Bachelor's degree with 4+ years of relevant work experience preferred 

  • Aseptic experience preferred, but not required 

WORKING CONDITIONS (the 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 gowned in a clean-room 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.

Contact:

Full Name: Suproteem Bagchi 

Email ID: suproteemb@askconsulting.com

Phone Number: (678) 276-8265