Quality Assurance Manager - United States
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Manages and coordinates the company's outsourcing facility quality assurance program including oversight and enforcement of all quality processes that relate to patient safety and regulatory requirements by performing the following duties personally or through other outsourcing pharmacy operations personnel.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Manages and coordinates all company quality processes audit functions.
Develops quality assurance policies and procedures, training requirements, and competency evaluations.
Develops gap analysis documents to ensure outsourcing facility and pharmacy task completion.
Implements local, state, and national regulatory agencies' requirements.
Advises outsourcing facility, pharmacy management and other pharmacy personnel of quality processes and provides any necessary training or training support.
Conducts periodic and special surveys of outsourcing facility and/or pharmacy processes to determine adequacy and capability of quality assurance and ability to comply with complete quality specifications.
Reviews quality problems with outsourcing facility and/or pharmacy operations management and clinical pharmacists and determines any required corrective action.
Manages corrective action within outsourcing facility and/or pharmacy including any recommended appropriate retraining, written warnings, and/or disciplinary action.
Prepares periodic and special reports concerning quality assurance activities, problems, and other quality related events.
Prepares/publishes quarterly quality documents.
Conducts quarterly quality meetings within the outsourcing facility and pharmacy as well as any ad hoc meetings necessary to address immediate issues.
Meets with outside vendors and assists in the assessment of new equipment needs related to the quality process.
Comprehensive understanding of pharmacy, cGMP and FDA regulations.
Interfaces with state and federal agencies during regulatory inspections.
Note: The above statements describe the general nature and level of the work being performed and are not an exhaustive list of all responsibilities of an employee in this job. Job duties can change at any time as directed by management. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the employer.
Set yourself apartQUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor's degree in an Applied Science (preferred in Microbiology) or equivalent combination of education and experience.
6-10 years of experience in a regulated pharmaceutical or pharmacy environment and a minimum of 3 years in pharmaceutical cGMP
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Ability to operate a personal computer
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
CERTIFICATES, LICENSES, REGISTRATIONS
GMPCP Certification preferred
PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee frequently is required to sit; stoop, kneel, crouch, or crawl; and taste or smell. The employee must regularly lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.
WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly exposed to risk of radiation. The employee is frequently exposed to moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals. The noise level in the work environment is usually moderate.
Provides oversight and direction to outsourcing facility personnel, pharmacy management and other pharmacy personnel regarding pharmacy quality assurance.
What’s on offer?Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.
Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a generous company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.