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Job DescriptionAt Fisher BioServices, we specialize in the management of critical biological materials in support for the advancement of cell therapy, high value biologics, and population-based public health research. We provide customized end-to-end chain of custody solutions for our large pharmaceutical clients and partners in academia and government, ensuring the integrity and efficacy of their valued material from the manufacturer to the bedside. Fisher BioServices is a brand of Thermo Fisher Scientific, the world leader in serving science, and member of the BioPharma Services Division. To learn more please visit www.fisherbioservices.com .How will you make an impact?This position is within the Fisher BioServices business unit of Thermo Fisher Scientific. The Quality Assurance Manager drives day-to-day activities within a Quality Assurance function or across a site and is responsible for the resolution of issues with customers (internal and external) and suppliers that relate to quality.What will you do?
Support all staff in Quality Assurance to ensure ongoing safety.
Support Quality Assurance staff that report directly to them within the Quality Assurance matrix while leading staffing and selection of candidates within the team they manage for qualification programs. Ensuring necessary qualification in a timely manner, reviewing needs with other functional managers for the benefit of the overall organization.
Conduct PMD(s) for direct reports in collaboration with others, and to input on PMDs for all staff qualified within the function managed.
Provide a Quality Assurance training program, which includes assessment, for their function presenting opportunities for both classroom and practical application of quality related procedures, as appropriate.
Manage and maintain functionally qualified resources in collaboration with other managers.
Supervise Quality Assurance Associate/ Professional Activities: Ensuring protocols, methods, materials and equipment are applied and quality records maintained in a consistent and efficient manner. Training, coaching and mentoring others to achieve their potential.
Monitor Production/ Operational Quality: Through consolidation of key quality characteristics of processes, trend analysis and reporting through the Quality Assurance dashboard for identification of satisfactory and/ or unsatisfactory trends and conditions, as well as monitoring resolutions to result in systematic prevention of defects and non-conformances.
Manage Continuous Improvement Activities: Drives the creation, update and consolidation of necessary SOPs, change control and collection of data or measurement of critical compliance values as part of the Fisher BioServices continuous improvement plan and determines, in co-operation and through recommendation with line management how such data will be represented to the organization. The Quality Assurance Manager maintains responsibility for tracking and facilitating to closure corrective and preventative actions within their function, or site of responsibility.
Main QA functions handled include, but are not limited to, master document review/approval, label specification review/approval, audit management, training management, batch record review/approvals, QTA and questionnaire management.
Education/ Experience:
Bachelor's Degree in a Scientific/Technical field (i.e. Chemistry, Biology, or Engineering) minimally required.
5+ years of hands-on Quality experience in a cGMP environment
Knowledge of the pharmaceutical GMP regulations and their appropriate application is needed to assure compliance with regards to manufacturing problems.
Knowledge of software compliance (21CFR; Part 11)
Detailed knowledge of cGMPs for medical devices or pharmaceuticals.
Knowledge/Skills/Abilities:
Proficiency with personal computer skills, specifically Microsoft office applications, with the ability to learn new computer systems quickly.
Effective communication skills are required, both written and verbal.
Problem solving skills are required in situations that are not procedurally managed.
Consistent attention to detail/follow up.
Excellent planning/organization skills, strategy and customer focus.
Ability to prioritize multiple tasks while ensuring timely and accurate completion.
Ability to work independently.
Prior leadership experience preferred.
Supervisory Responsibility:Manages Quality Specialists.Work Schedule:
8:00AM to 5:00PM core hours, additional hours as required.
Requires ability to travel on a regional or national level to support the needs of the business 5% of the time.
Work Conditions/Physical Requirements:
Ability to work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents and marked changes in temperature.
May push/pull 600 lb liquid nitrogen dewars, and work from a platform ladder.
Must use personal protective equipment and adhere to safety protocols.
Must be able to lift and carry up to 50 lbs, and push up to 70 lbs.
Must be able to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-195°C) for up to 6 hours per day.
Must be able to work in walk-in freezers or refrigerators periodically for up to 5 hour per day.
Must be able to use a computer up to 6 hours per day.
At Thermo Fisher Scientific, each one of our 100,000+ extraordinary minds have a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Full-time