Position Title:    Specialist, Sterility Assurance Quality Assurance Shop Floor. 
Location:    Summit West, S-12
Duration: 6 Months

Wed - Sat 7 am - 530 pm

PURPOSE AND SCOPE OF POSITION:
The Specialist is responsible for quality activities for the QA shop floor in accordance with internal policies, standards, procedures and Global cGMP. This position is part of the sterility assurance team with a focus on contamination control strategies. 
Functional responsibilities include ensuring manufacturing compliance with applicable procedures and working with operations to resolve manufacturing issues. 

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities:
•    Must have advanced knowledge and experience with cGMP manufacturing, Quality, and Compliance.
•    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.
•    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.
•    Understands Environmental Monitoring, disinfection principles as well as aseptic/cleanroom environments. 
•    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.

Education and Experience:    
•    High School Degree required.
•    Relevant college or university degree preferred. 
•    Minimum 5 years relevant work experience.
•    Equivalent combination of education and experience acceptable.

DUTIES AND RESPONSIBILITIES:
•    Perform QA shop floor oversight ensuring proper aseptic techniques.
•    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 change control, deviations, investigations, and CAPA management.
•    Able to effectively multi-task.
•    Must be available for weekend and off-shift hours.

WORKING CONDITIONS (US Only):
Work is performed in a typical office (with standard office equipment available and used) and manufacturing suite environment. While in the office, work is generally performed seated, but may require standing and walking when on the floor. 
Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc. 

  
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 41.72/hr.