24 days old

Pharmaceutical Manufacturing Material Qualification Specialist:Temp-to-permanent

Kelly Services
Cambridge, MA 02238
**Kelly Services** is currently seeking a **Material Qualification Specialist** in **Cambridge, MA** to work a 6 **month temp-to-permanent assignment** for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.

**Primary Responsibilities of the Material Qualification Specialist includes:**


Support sites with global material qualification procedures and program (including HDE)

Support global material qualification training

Support material qualification assessments and efforts for CMO programs

Support global MQ knowledge management initiatives


Support global MQ network (internal and external) as SME, providing training, inspection support, change assessment support and overall project technical and strategy expertise as required, including HDE trainings and peer review of calculations as needed.

Support CMO programs by providing guidance, execution gap assessments, coordinating E/L testing, executing MQ and providing MQ packages

Lead analysis (such a SWOT) of publicly available business intelligence (10-Ks, journals, etc.) to identify business trends and opportunities in material selection, implementation and qualification.

Support MQ global knowledge management activities throughout MQ network including sharepoint, MS Teams, Yammer and database efforts.


Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical knowledge)

Analyze unstructured problems, identify root causes and align team objectives to drive divisional goals

Use agile principles to reduce process complexity and increase organizational capacity

Extensive knowledge of essential CMC activities

Develop and apply custom strategies for processing and visualizing multidimensional data

Experience capturing and translating business requirements into technical solutions

Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)

Experience managing projects in a matrix environment

A firm grasp of organizational development and cross-functional group alignment

Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)

Exercise judgment within defined procedures and practices to determine appropriate action.

Work in a dynamic environment, be able to set, balance and communicate priorities, and serve as a change agent.

Develops concise, strategic plans based on a clear understanding of the organizations strengths, weaknesses, opportunities and threats.

Interaction (The span and nature of ones engagement with others when performing ones job, internal and external relationships)

Exerts influence on the overall objectives and long-range goals of the organization.

Represents organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations.

Strong interpersonal and active problem-solving skills

Engage partners to deliver agile and predictive results within a complex and evolving business landscape

Interface with each Operating Unit and Region supporting lifecycle management of development and commercially approved products

Build productive working relationships internally and externally.

Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)

Leverage business analytics (such as SWOT) to identify emerging opportunities and capability needs for GMSci.

Ability to apply first principles in chemistry, physics, and engineering to manufacturing problems and create new solution paths to manufacturing challenges.

Translate prior knowledge into new understanding of the development pipeline and expand the working knowledge of the essential activities for all key functional areas

Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.

Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)

Understands differences in practices across organizations or countries, and balances local demands and perspectives with global strategies.

Creates an environment that promotes information exchange and the open and honest expression of opinions, thoughts and beliefs.


Education / experience

Minimum requirement of:

o Bachelors degree in Science or Engineering related field and 3+ years working within commercial bio/pharmaceutical manufacturing or related field

o Bachelors degree in Science or Engineering, Masters in Business Administration, and 2+ years working within bio/pharmaceutical manufacturing or related field

o Ph.D. in Science or Engineering related field

Strong knowledge of pharmaceutical development, manufacturing operations, and product quality


Expert knowledge of Microsoft tools (Excel, SharePoint, etc.)

Strong interpersonal skills with the ability to motivate and influence others, negotiate during situational conflict, and establish the best forward path in the face of competing points of view.

Ability to articulate complex issues and ideas with clarity to enable understanding and timely decision making.

Background in material sciences, analytical chemistry or material qualifications preferred.


**For immediate consideration, please send your resume in a WORD document to**

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

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**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. 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.

Posted: 2020-05-11 Expires: 2020-06-11

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Pharmaceutical Manufacturing Material Qualification Specialist:Temp-to-permanent

Kelly Services
Cambridge, MA 02238

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