QC Inspector

SUMMARY:

Oversees logs and procedures and ensures Q.C. and Production are abiding by GMP and GLP company rules set forth by company SOPs. Ensuring things are made right in the first place is the best way of preventing out of specification products.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Includes the following, but other duties may be assigned as the company's needs dictate. Reviews and approves the Production filling batch records. Checks and audits the documents for accuracy and GMP compliance during and at the completion of filling. Checks and confirms that the correct components and compounding batch have been set-up and are being used on the appropriate packaging line. Reviews the data reported by the mechanics, machine operators, and line leads to ensure that the information is correct and entered appropriately. Responsible for placing compounded batches and finished goods that do not conform to company specifications into Quarantine status with applicable labeling. Reports any quality issues to Quality management and participates in investigations, as necessary. Performs daily housekeeping audits of the Production area logbooks and reports results to Quality management. Supports GMP training of employees. Participates in Quality System audits as directed by Quality management. Complies with Health, Safety, and Environmental responsibilities for the position. Inspects the production lines to ensure that both Production and Quality control personnel are following the required SOP to perform their jobs.

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/or

EXPERIENCE

High school diploma or GED (general education degree) and some college (science-based courses preferred). Minimum 6-months of hands-on experience as Quality audit/inspector in cGMP environment; preferably in pharmaceutical, biomedical, or medical device field (regulated industry). Experience with batch record keeping, CAPA initiation, and deviation investigation. Should have experience working on the floor of a manufacturing facility.

LANGUAGE SKILLS

Fluent in reading, writing, and speaking the English language, as well as having experience with technical writing (knowing Spanish is a plus). Ability to read, analyze, and interpret 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 departmental manager/supervisor or other employees.

MATHEMATICAL SKILLS

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.

COMPUTER SKILLS

To perform this job successfully, an individual should have knowledge of Database software, Spreadsheet software and Word Processing software.

REASONING ABILITY

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.

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 frequently required to sit, use hands to finger, handle or feel; and reach with hands and arms. The employee is occasionally required to stand, walk, talk or hear, and taste and smell. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, 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 frequently exposed to fumes or airborne particles (herbal powders). The noise level in the work environment is usually quiet. Sunrider Manufacturing provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.