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Job #03620

About our client Our client is a leading biomedical company based in Ohio. They focus on the development and commercialization of surgical and diagnostic products that enhance patient care. Position Location Quality Assurance Manager Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure the continued compliance with integrated Quality Management System and processes 2) Meet the requirements of the regulatory agencies in the US, Europe, Japan, Canada as well as other international regulatory agencies 3) Plan, implement and revise programs and procedures that ensure appropriate practices and standards relevant to the control of device, drug and biological product quality and efficacy 4) Implement all procedures leading to compliant, valid and documented release of device, drug and biologic product by performing the duties 5) Participate in developing and approving validation programs for facilities, manufacturing processes, products, environmental classifications, etc. 6) Maintain quality management system and processes to ensure changes to programs, procedures, and processes are approved and appropriately documented and validated 7) Work with suppliers to ensure that company and supplier facilities pass regulatory inspection(s) 8) Serve as the audit host for all regulatory inspections for company and suppliers 9) Direct audit program to review facility, personnel and equipment qualifications of suppliers 10) Ensure compliance with company and regulatory specifications regarding competence, purity, size, quality and durability 11) Perform audits of products and processes to identify areas for improvement 12) Maintain GMP at company, suppliers and study sites 13) Oversee product complaints, deviations and failure and out-of-specification investigations 14) Provide quality assurance support for regulatory submissions 15) Manage records and disposal of radioactive and bio-hazardous materials 16) Pursue training and development opportunities and strive continuously to build knowledge and skills 17) Share expertise with others 18) Manage difficult or emotional customer situations 19) Respond promptly to customer needs and request for service and assistance 20) Meet commitments 21) Prioritize and plan work activities, use time efficiently, sets goals/objectives and develop realistic action plans. 22) Approach others in a tactful manner, react well under pressure, treat others with respect and consideration regardless of their status or position 23) Accept responsibility for own actions and follow through on commitments 24) Meet productivity standards and complete work in timely manner 25) Observe safety and security procedures and use equipment and materials properly 26) Adapt to changes in the work environment 27) Manage competing demands, change approach or method to best fit the situation and deal with frequent change, delays, or unexpected events 28) Follow instructions, respond to management direction and take responsibility for own actions 29) Undertake self-development activities, seek increased responsibilities, take independent actions and calculated risks 30) Look for and take advantage of opportunities 31) Ask for and offer help when needed 32) Display original thinking and creativity 33) Meet challenges with resourcefulness and generate suggestions for improving work Requirements 1) College degree in Biological Sciences 2) Minimum 5 – 10 years of significant quality assurance experience in manufacturing biopharmaceuticals or pharmaceuticals or equivalent combination of education and experience 3) 5 – 10 years of quality assurance experience in a GMP environment 4) Experience in regression analysis and chemistry 5) Experience in software validation 6) Experience in audits, QMS management and validations 7) Good knowledge of business software including Microsoft Access 8) Good computer knowledge (word and excel as well as statistical and quality control software applications) 9) Excellent communication, organizational, project management and strong analytical skills and demonstrated attention to detail 10) Ability to focus on solving conflict, maintain confidentiality 11) Ability to listen to others without interrupting, keep emotions under control, remain open to others' ideas and tries new things 12) Ability to speak clearly and persuasively in positive or negative situations, listen, get clarification and respond well to questions 13) Demonstrated group presentation skills combined with willingness to participate in meetings 14) Ability to write clearly and informatively, edit work for spelling and grammar, vary in writing style to meet needs and present numerical data effectively 15) Ability to read and interpret written information 16) Ability to balance team and individual responsibilities, exhibit objectivity and openness to others' views and put success of team above own interests 17) Ability to support everyone's efforts to succeed 18) Ability to inspire, respect and trust 19) Ability to build commitment, overcome resistance, monitor transition and evaluate results 20) Ability to exhibit confidence in self and others, effectively influence actions and opinions of others 21) Ability to always look for ways to improve and promote quality and demonstrate accuracy and thoroughness 22) Ability to understand business implications of decisions and demonstrate knowledge of market and competition 23) Ability to align work with strategic goals, work within approved budget and conserve organizational resources 24) Ability to promote a harassment-free environment 25) Ability to treat people with respect, keeps commitments, inspire the trust of others, work with integrity and ethically upholds organizational values 26) Ability to follow policies and procedures, complete administrative tasks correctly and on time and support organization's goals and values 27) Ability to develop strategies to achieve organizational goals and adapt strategy to changing conditions 28) Ability to display willingness to make decisions, exhibit sound and accurate judgment, support and explains reasoning for decisions 29) Ability to include appropriate people in decision-making process and make timely decisions 30) Ability to motivate, set and achieve challenging goals 31) Ability to persistence, overcome obstacles, measure self against standard of excellence and take calculated risks to accomplish goals 32) Demonstrated accuracy and thoroughness 33) Ability to look for ways to improve and promote quality 34) Ability to monitor own work to ensure quality 35) Ability to keep commitments, complete tasks on time or notify appropriate person with an alternate plan 36) Ability to analyze and synthesize complex or diverse information 37) Ability to collect, conduct research on data and use intuition and experience to complement data 38) Ability to design, apply design principles 39) Demonstrated knowledge of device, drug and biologic GMP, as well as quality and manufacturing responsibilities associated with the US FDA and other international regulatory agencies 40) Ability of technical writing and statistical analysis 41) Ability to read and interpret documents such as regulations, industry standards, blue prints, bills of materials, product, process specifications, safety rules, operating, maintenance instructions and procedure manual 42) Ability to write routine reports and correspondence 43) Ability to speak effectively before groups of customers or employees of the organization 44) Ability to work with mathematical concepts such as probability and statistical inference and fundamentals of plane and solid geometry and trigonometry 45) Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations 46) Ability to apply common sense understanding in order to carry out instructions furnished in written, oral or diagram form 47) Ability to deal with problems involving several concrete variables in standardized situations 48) Ability to productively and accurately apply statistical, database, design, internet, manufacturing, project management, spreadsheet and word processing software applications 49) Certified Quality Auditor (CQA), Certified Quality Manager (CQM), or Certified Quality Engineer (CQE) 50) Ability to audit products and processes to approved specifications, quality standards and regulations (GMP/GCP/GLP) 51) Ability to be punctual at work and on time and arrive at meetings/appointments on time 52) Ability to identify and resolve problems in a timely manner 53) Ability to gather and analyze information skillfully 54) Ability to use reason when dealing with emotional topics 55) Ability to develop alternative solutions and work well in group problem solving situations 56) Ability to develop project plans, communicate changes, progress and complete projects on time and budget 57) Willingness to commit to long hours of work when necessary to reach goals 58) Willingness to travel (up to 40% of the time, or as circumstances dictate)