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13 days old

Senior Quality Assurance Specialist

Kelly Services
Devens, MA 01434
**Kelly Scientific has been providing outstanding employment opportunities to top talent individuals in the marketplace. We are looking to fill a** **_Senior Quality Assurance Specialist_** **role with one of our top clients in** **_Devens, MA._**


**Title:** Senior Quality Assurance Specialist


**Pay: $** 66.52/hr


**Location:** Devens, MA


**Duration:** 6 months + possible extensions


**Shift:** Day Shift


**Employment Type** : Full time- 40 hrs/wk


The Senior Quality Specialist is responsible for performing visual inspection and disposition activities at the Devens, MA Cell Therapy manufacturing facility, in accordance with client policies, standards, procedures and Global cGMP. The role will directly contribute to the routine and timely release of incoming materials such as consumables, raw materials, and viral vector in compliance with all applicable regulations and guidelines. Functional responsibilities include performing material release within the inventory management system (SAP), ensuring accurate and timely maintenance and review of batch related documentation, incoming material visual inspection, and close coordination and planning with Supply Chain.


**DUTIES AND RESPONSIBILITIES**


Participates in the startup of the Devens Cell Therapy facility, including the drafting of Standard Operating Procedures, training, and business processes supporting incoming material disposition and visual inspection of incoming materials.


Perform incoming material inspection and disposition using SAP.


Actively participates in and provides recommendations for procedural and business process clarifications to ensure robust SOPs and processes are in place.


Verify accuracy and acceptability of documentation, such as Certificate of Analysis or deviation reports, to support material disposition.


Perform required updates to lot status in applicable quality systems. Ensure lot disposition status is monitored and communicated to appropriate stakeholders.


**Required Competencies:**


Must have knowledge and experience with cGMP manufacturing, Quality, and compliance as well as US and global cGMP requirements.


Demonstrates a high degree of attention to detail, with strong documentation expertise. Able to effectively multi-task and demonstrate strong organizational skills.


Excellent verbal and written communication skills with ability to prepare written communications and communicate problems to management with clarity and accuracy.


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.


Requires direction to complete more complex tasks; completes routine tasks with little supervision. Confident in making decisions for minor issues and routinely recognizes Quality issues and solves problems.


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


In depth knowledge of ERPs (such as SAP) is highly desired.


Knowledge of electronic systems including any of the following: Veeva, LIMS/Celabs, Infinity, and electronic batch recording.


Knowledge of quality processes, tools, and methodologies.


**Must Have Qualifications:**


B.S. in a life or physical science related discipline.


Minimum of 5 years of pharmaceutical experience or related GMP industry.


Previous direct experience in SAP, Material Disposition, Incoming Inspection, or similar quality assurance roles is highly desired.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits (https://www.mykelly.us/us-mykelly/perks/) ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-09-06 Expires: 2021-10-07

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Senior Quality Assurance Specialist

Kelly Services
Devens, MA 01434

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