QC Inspector

The Sunrider Corporation•Midlothian, TX

22d

About The Position

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.

Requirements

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.
Fluent in reading, writing, and speaking the English language, as well as having experience with technical writing
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.
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.
knowledge of Database software, Spreadsheet software and Word Processing software.
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.

Nice To Haves

knowing Spanish is a plus

Responsibilities

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.