Quality Control Manager manages the inspection and testing of materials, parts, and products to ensure adherence to established quality standards. Proposes corrective actions to improve compliance with quality specifications. Being a Quality Control Manager recommends new or improved quality control methods, procedures, and/or standards. Requires a bachelor's degree. Additionally, Quality Control Manager typically reports to a head of a unit/department. The Quality Control Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Quality Control Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Summary: This position is responsible for contributing to the assurance that clinical trials are conducted, and data is generated, documented, and reported in compliance with internal standards, ICH/GCP, and applicable FDA regulatory requirements. Performs duties in accordance with company’s values, policies, and procedures.
Essential Duties and Responsibilities include the following. Other duties may be assigned at the company’s sole discretion.
Competencies:
Qualifications:
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 Experience:
Associate degree in life sciences or related field with at least one year of research experience in the clinical area of a pharmaceutical, CRO, medical device company, or related organization. A significant work history in clinical research with a demonstrable knowledge of GCP and GDP principles may be considered in lieu of an associate degree. Basic understanding of ICH/GCP guidelines, including a basic understanding of regulatory requirements and the clinical trial process or equivalent combination of education and experience is required. Experience working in QA/QC department reviewing clinical trial documents and data (source data and regulatory documents), knowledge of medical terminology, clinical research acronyms, and medical/scientific abbreviation and writing Standard Operating Procedures (SOPs) and/or Work Instructions (WIs) is desired.
Skills, Knowledge, and Abilities:
Working knowledge of FDA 21 CFR regulations for clinical research as well as ICH, GCP guidelines; demonstrated leadership skills; strong judgment, initiative, and problem-solving skills. Ability to perform clinical data review of source documents and case report forms independently and accurately. Ability to follow study specific guidelines, plans, and manuals, and participate in all aspects of training in addition to performing verification and resolution of data queries/discrepancies within defined timelines. Excellent written and oral communication skills. Ability to work to strict deadlines, prioritize, and remain calm under pressure. Diligently pays attention to details and pursues quality in accomplishing tasks.
Language Ability:
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, employees, and the general public.
Math Ability:
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Reasoning Ability:
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.
Computer Skills:
To perform this job successfully, an individual should have computer skills with intermediate to advanced abilities with the current Microsoft Office Suite as well as Windows applications. Must have electronic document management experience. Ability to quickly learn and use new software systems. Experience working in electronic source (esource) data platforms is desired.
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 occasionally exposed to work near moving mechanical parts; work in high, precarious places and fumes or airborne particles. The noise level in the work environment is usually quiet to moderate.
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.
The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to stand; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to walk and stoop, kneel, crouch, or crawl.
The above job description does not imply these outlined duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.
ProSciento reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and company.
ProSciento is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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