Product Safety Specialist

Title:Product Safety SpecialistLocation:Portland, ME 04106 Duration: 06 MonthsDescription: The key to successful treatment and full recovery is often fast, accurate diagnosis. Client s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health. Our pioneering technology spans the world of healthcare operations with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics. The function is responsible for ensuring divisional compliance with regulations and internal standards for Product Safety and Safety Data Sheet (SDS) generation. The function acts as a source of expertise within the division regarding product and chemical regulations and maintains a divisional program with clear program elements, goals/priorities, strategy, and resources. The position will coordinate with assigned sites with the objective of organizing and obtaining accurate product composition information necessary for the generation of product safety data sheets for final products and intermediates. The position will develop a standardized product composition template and process. Strong scientific communication is essential to the role as is the ability to manage long and complex projects. This role will liaise between Technical Product Support, R&D, site-level Operations, Quality Assurance, Regulatory Affairs, and outside suppliers/vendors. The ideal candidate will possess a strong scientific background with a M.S. Or PhD in biochemistry, chemistry or biology, excellent communication skills, the desire to direct others to complete tasks/projects, a team-centric attitude, and creative/innovative problem-solving skills. The candidate must be a self-starter with a very high degree of commitment, technical skill, and dedication.What You ll Do:

• Understands and supports the EHS sections of the SDS and develops / maintains the SDS inventory for Finished products and intermediates.
• Develops and maintains formal Product Safety systems and programs to ensure adequate organization. Partners with quality and operations to ensure Product Safety requirements are incorporated into process design/development and manufacturing.
• Conducts part/product assessments to identify impacts of Product Stewardship regulations in the supply chain.
• Supports the development of the Product Composition and SDS strategy with the sites and/or with the other division functions, and interface with 3rd party consultants.
• Support the development of a long-range plan for Product Safety and Product Stewardship strategy, considering long term goals and continuous improvement.
• Exhibits advanced ability to apply concepts of careful communication.
• Manages multiple, often concurrent, projects and meets deadlines.
• Follows through on goals and incorporates the ideas of others;shares resources, knowledge and accountability to benefit the objectives of the business.

Education and Experience You ll Bring

• B.S., MS or PhD in Biochemistry, Chemistry, Biology, Chemical Engineering, Biotechnology, or a related technical field

Preferred:

• 5+ years in the Biotechnology industry with a significant focus in product safety and/or product stewardship experience
• Expertise in Safety Data Sheet (SDS) generation
• Experienced with regulations and internal standards for Product Safety
• Proven track record of technical project management/oversight.
• Candidates should work well in a team environment and have flexibility to work on changing priorities.

Skills:

• Product Safety
• Safety Data Sheet
• EHS
• Product Stewardship
• Self-Starter
• Chemical Engineering
• Biochemistry
• Problem-Solving Skills
• Technical Skill
• Communication
• Performance
• Creative
• Innovative
• Technical Projects
• Physical Sciences
• Chemistry
• Quality Assurance
• Biotechnology
• Detailed
• Excellent Communication Skills
• Biology
• Task Completion
• Dedication
• TRAVEL - NO
• MEDICAL SURVEILLANCE - NO
• SIGNIFICANT WORK ACTIVITIES

• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day)
• Continuous standing for prolonged periods (more than 2 consecutive hours in an 8-hour day)
• Keyboard Use (greater or equal to 50% of the workday)
• Work in a Clean Room Environment
• Responsible for implementing and maintaining the effectiveness of the quality system. Possesses a recognized expertise in theories;principles and analytical tools.
• Broad knowledge of related disciplines. Develops solutions to a wide range of complex problems where in-depth analysis is required. Understands the organization's mission;goals;strategies;strengths;and weaknesses and the larger framework within which their responsibilities lie.
• Understands how other parts of the organization function.
• Maintains a working knowledge of what other groups do in the company. Uses broad knowledge of what people in other functions do to complete the tasks at hand.
• Establishes or provides input to multiple priorities or tasks;develops action plan to accomplish assigned activities to specification (quality;time) and sets timelines to accomplish tasks.
• Establishes measurable project goals and implementation plans;balances;conflicting work demands.