Spec Quality Control - San Juan Capistrano, CA - Monday-Friday
The Quality Control Specialist responsibilities include; testing, inspection and release of raw materials and manufactured product and completion of all related documentation. Position further encompasses troubleshooting, creating and maintaining of testing documents, supporting non-conformances and deviations. Specialist will be responsible for projects as defined departmental and company goals. Will represent Quality on projects, committees and or teams as necessary. Supports all applicable regulations including but not limited to FDA, ISO, and IVDD requirements.
ESSENTIAL DUTIES & RESPONSIBILITIES
Inspects, tests, and releases incoming raw materials according to specifications.
Inspects, tests, and releases manufactured components and kits according to specifications.
Effectively interprets, presents and explains technical information, training material, and/or procedures.
Performs and evaluates/develops new in-house protocols on project basis. Facilitates the development of new specifications, parameters, and test procedures. Responsible for transitioning new testing processes and procedures for new products.
Oversees investigations of process deviations, product non-conformance etc. Analyzes data, provides written investigations with recommendations for corrective/preventive actions.
Assists in updating raw material and product disposition status.
Works independently and exercises appropriate judgment and discretion so to represent Quality management where appropriate.
Develops and maintains two-way communication with Manager and other cross functional team members. Take initiative in sharing opinions, ideas, and knowledge.
Reviews, revises and streamlines current testing procedures/protocols and raw material specifications. Provides training on new procedures as required.
Assists area supervisor in training and compliance of area related procedures and SOPs.
Assists in multi-departmental cross-training efforts.
Perform other duties as assigned.
Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health-related programs and assist in solving safety and health problems. Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process.
EDUCATION and/or EXPERIENCE
Bachelor’s degree in the Sciences, Chemistries or the equivalent; one to two years related experience and/or training; or equivalent combination of education and experience. Working knowledge of GMP, GLP and ISO required.
Ability to read, analyzes, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from management, peer group and others.
Ability to apply advanced mathematical concepts such as logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as determination of test reliability and validity, analysis of variance, correlation techniques, etc. Ability to perform and interpret statistical analysis of data
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to learn and rapid assimilate new tasks, tests etc. Able to multitask
Ability to use pipettors and routine and/or specialized laboratory equipment accurately and consistently. Computer literate. Able to analyze data using computer methods. Working knowledge of Microsoft EXCEL and/or others for generation of tables, charts, graphs and reports
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and talk or hear. The employee is frequently required to walk, sit, and reach with hands and arms. The employee must occasionally stand and lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
While performing the duties of this job, the employee is occasionally exposed to toxic or caustic chemicals, moving mechanical parts, fumes or airborne particles, bio-hazardous or other infectious materials. The noise level in the work environment is usually moderate.