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Quality Assurance Manager
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Wright-Pierce Tallahassee, United StatesWelcome to the Latest Job Vacancies Site 2024 and at this time we would like to inform you of the Latest Job Vacancies from the · Red Sun Technology · with the position of · Quality Assurance Manager - REMOTE - Red Sun Technology · which was opened this. · If this job matches ...
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Quality Assurance Manager
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Quality Assurance Manager
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Quality Assurance Manager
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Quality Assurance Manager
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Quality Assurance Manager
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Quality Assurance Manager
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Quality Assurance Manager
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Quality Assurance Manager
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Quality Assurance Manager
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Compliance Quality Assurance Manager
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Quality Assurance Lead
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Supervisor, Case Management
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Quality Assurance Analyst
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Quality Assurance Manager - Tallahassee, United States - LFB Plasma
3 weeks ago
Description
Job DescriptionJob Description
The Manager of Center Quality Assurance is responsible for the daily oversight of the center's Quality Management system.
RESPONSIBILITIES
Responsible for all quality personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination, and the maintenance of all quality personnel records.
Oversee daily actions that facilitate product collection (sample collection and submission; testing results, staging).Assist the Quality Assurance Unit (QAU) in ensuring donor center records are complete and accurate.
Ensure shipments (sample, product, waste, etc.) are managed and labeled accurately.
The interpretation and application of SOPs; and, ensuring SOP revisions are implemented correctly, efficiently, and effectively
The receipt, approval, and release of donor center supplies.
Assist Center Management and Training Coordinator to ensure training is conducted and documented as directed, review and prepare for
inspections/audits,
and to develop CAPA, and other quality duties as assigned.
Oversee and manage the center's Deviation Management System to ensure adequate investigations are completed, accurate root cause(s) identified, and CAPA process is identified and managed.
Track and trend the center's quality and operational metrics with respect to applicable SOPs.Perform periodic self-assessments of the center's quality and compliance.
Supervise the center's Quality Assurance Unit employees.
Responsible for working through multiple projects and managing multiple competing priorities.
Other duties as assigned
QUALIFICATIONS
Bachelor's Degree in a scientific discipline, life sciences or related discipline preferred or (12) twelve months experience related to quality, regulatory or related industry provided that the experience was obtained in a regulated environment.
Necessaryeducation/experience
may be substituted for the position with approval from the Director of Quality Assurance or VP of Quality Assurance.
Must be fully signed off and capable of performing the duties of the Manager of Quality Assurance.
Demonstrate expertise in interpreting cGMPs, FDA regulations, and SOP development, as well as an understanding of quality principles.
Good oral and written communication skills.
Ability to work independently with little supervision.
Strong verbal and written communication skills.
Proficiency with computers.
Must have explicit attention to detail.
Must have excellent analytical skills, organization skills, and follow-up.
Use hands to handle or feel objects, tools, or controls; reach with hands and arms; and talk or hear.
Frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee.
Manual dexterity to perform all phases of donor plasmapheresis.
Ability to stand for extended periods of time for up to four (4) hours at a time.
Ability to sit for extended periods of time for up to (4) hours at a time and view a computer screen.
Ability to lift, tug, pull up to fifty (50) pounds.Ability to travel by plane, or car as required to train or assist other centers as needed.
Typical work environment with moderate noise level.
May be exposed to freezing temperatures for short periods of time.
Occupational exposure to bloodborne pathogens.
Company Description LFB is a bio-pharmaceutical company that develops, manufactures and markets plasma derived products and recombinant proteins for the treatment of patients with serious and often rare diseases.
Founded in 1994 in France, LFB is one of the leading European bio-pharmaceutical companies providing mainly hospital-based healthcare professionals, with blood derived therapeutics with the vision to provide treatment options to patients in three major areas – immunology, haemostasias and intensive care.
Company Description
LFB is a bio-pharmaceutical company that develops, manufactures and markets plasma derived products and recombinant proteins for the treatment of patients with serious and often rare diseases.
Founded in 1994 in France, LFB is one of the leading European bio-pharmaceutical companies providing mainly hospital-based healthcare professionals, with blood derived therapeutics with the vision to provide treatment options to patients in three major areas – immunology, haemostasias and intensive care.
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