Job Descriptions in Quality Control, Quality Assurance and Validation
Director of Quality
Job Description
Responsible for short and long term goals of quality control (QC) laboratory efforts in support of IND, NDA and commercial products and other milestones. Formulates and recommends quality assurance (QA) policies and programs. Develops departmental budget for quality assurance and quality control, including defining materials, equipment and personnel needs. Directs QC staff and daily operations to include: release and stability testing, in-process testing, QC inspections and audits, QC documentation, equipment maintenance and calibration and QC laboratory design and maintenance. Manages GMP material control program to include: QC materials management including labeling and storage, QC materials inventory and use and materials lot control. Oversees component and finished product stability program, transfer of validated methods to routine use, and participation of QC staff in support of validation of methods and equipment. Establishes and directs QC control programs and GMP training programs. Reviews and approves reports and other documentation prepared by QA and QC for regulatory submissions/inspections. Assures finished products conform to government and company standards and satisfies GMP regulations.
Education/Experience
Require BS or MS in chemistry or equivalent science and 6-10 years plus in chemistry, quality control and/or laboratory management positions plus experience in GMPs/GLPs.
Quality Control (QC) Manager/Supervisor
Job Description
Supervises the development, implementation and maintenance of quality control systems and activities. Oversees development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy, efficacy and reliability of products. Coordinates interdepartmental activities. Develops budgets and monitor expenditures. Provides guidance to employees and supervises the work group. Responsible for regulatory inspections and findings including all follow-up.
Education/Experience
Requires BS/MS in a related discipline or equivalent and a minimum of 3-5 years' experience with documentation and implementation of quality control systems.
Quality Control (QC) Analyst
Job Description
Conducts routine and non-routine analysis of raw materials, in-process and finished formulations under supervision and according to Standard Operating Procedures (SOPs). Compiles data for documentation of test procedures and prepares reports. Calibrates and maintains lab equipment. Reviews data obtained for compliance to specifications and reports abnormalities. Revises and updates SOPs. May perform special projects on analytical and instrument problem solving.
Education/Experience
Requires BS in a scientific discipline or equivalent and a minimum of 0-4 years' experience. Senior positions require BS/MS with 3-7 years relevant experience. Previous experience in microbiology, chemistry or biochemistry is required.
Quality Control (QC) Technician
Job Description
Performs a wide variety of inspections, checks, tests and sampling procedures for the manufacturing process according to Standard Operating Procedures (SOP). Performs in-process inspection and documents results. Monitors critical equipment and instrumentation. Writes and updates inspection procedures and checklists as necessary.
Education/Experience
Requires a high school diploma, Biotech Certificate, AS degree or equivalent experience with a scientific background and a minimum of 0-5 years in quality control systems with knowledge of good manufacturing practices (GMPs). Entry-level positions require 0-2 years relevant experience. More experienced positions require a minimum of 2-5 years experience.
Quality Assurance (QA) Manager/Supervisor
Job Description
Assures that products, processes, facilities and systems conform to quality standards and governmental regulations; conducts internal audits to monitor processes, facilities and systems. Conducts raw materials audits. Reviews and approves operating procedures in Manufacturing and Quality Control departments. Assures that the Equipment Calibration Program complies with the GMPs requirements. Coordinates interdepartmental activities. Develops budgets and monitors expenditures.
Education/Experience
QA supervisory positions require BS in biological science and a minimum of 3-5 years' related experience in quality assurance and/or quality control. Managerial positions require BS/MS in a biological science with a minimum of 5-8 years plus related experience.
Quality Assurance (QA) Documentation Specialist
Job Description
Provides required documentation and implements documentation systems. Ensures the accuracy and completeness of the QA document system, performs daily filing, organizes contents and revises the table of contents. Processes, dates, issues and tracks batch record and other documentation. Maintains and updates the document control and tracking databases. Coordinates the review and revision of procedures, specifications and forms. Issues, distributes and updates controlled manuals. Assists in the compilation of regulatory filing documents and maintains computerized files to support all documentation systems. May assist the QA Manager in the training and orientation of Junior Documentation Specialists.
Education/Experience
Requires BS/MS in a related field and a minimum of 2 -5 years' experience in GMP Documentation Control documentation, quality assurance, or equivalent.
Quality Assurance (QA) Documentation Coordinator/Associate
Job Description
Responsible for providing clerical and administrative support related to documentation system requirements/maintenance. Audits all documentation manuals to assure they are accurate and up-to-date, and available to appropriate personnel. Maintains filing of all master documents and assists in all microfilming and archiving activities.
Education/Experience
Requires a high school diploma, Biotech Certificate, AS or equivalent experience and a minimum of 2-4 years' experience, preferably in documentation or quality control/assurance.
Validation Manager
Job Description
Is responsible for managing, developing and implementing validation protocols and test procedures to ensure products meet with appropriate regulatory agency validation requirements, internal company standards and industry current practices. Oversees and reviews validation area processes and procedures. Make recommendations for changes and improvements. May manage through subordinate supervisors the coordination of the activities of a section or department with responsibility for results in terms of costs, methods and employees.
Education/Experience
Requires BS/MS in a scientific discipline with 5-7 years' experience.
Validation Specialist
Job Description
Responsible for developing and recommending validation strategies and designing studies for the purpose of providing documented evidence that a system, equipment, method, or process has been validated. Conducts and processes qualifications programs, writes detailed protocols and reports to document the validation of systems/ equipment and provides validation support for facility and utility expansion, compliance upgrades, etc. Develops and implements solutions to validation issues.
Education/Experience
Requires BS in a scientific, engineering or other related technical field with a minimum of 3 years experience in a regulated industry. Knowledge of current industry practices and cGMP requirements related to validation tasks is required.
