QA Analyst

SUMMARY

Responsible for directing QA employees to perform the duties associated with QA activities and document control.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Administer the change control on company documents (SOPs), manufacturing (batch records) and regular procedures and ensure that appropriate training is documented and only the most current revisions are in use.

• Issues new documents (SOPs, test methods, test sheets, batch records, master formula and spec sheets). Update and/or change documents as required and assure documents accuracy.

• Review production paperwork and batch records by checking and auditing the documents for accuracy and completeness, calculate production yield and ensure compliance with the established specification limits.

• Ensure that the established QA/QC procedures are followed.

• Ensures that good documentation practices and good manufacturing practices are followed. • Promote and enforce GMP, GDP, Food Safety, FDA’s and company policies.

• Performs Monthly Internal GMP audits in all TXP departments, including production, QC, R&D, maintenance etc. and generate monthly GMP reports.

• Assists with FDA, ISO, NSF, Kosher, Halal and any other external audits.

• Assist in investigation of product failures and customer complaints as necessary and maintain Customer complaint files.

• Oversee the equipment, instruments and tools calibration program.

• Maintains environmental and pest control programs.

• Assists with and track the status of manufacturing investigations, laboratory investigations, special projects, customer complaints, process and document changes, CAPAs, risk assessments, vendor qualifications, etc.

• Assists in preparations of the annual product review reports and maintain appropriate files.

• Coordinates employees training program and oversee the completeness of employees training records.

• Assists in development of company’s Food Safety and Food defense plans, HACCP, process control and monitoring procedures.

• Stays up to date with current CFR pertaining to food, dietary supplements, cosmetic and drugs.

• Maintains Quality Assurance records and documents organized, audit ready and easily retrievable.

• Other tasks and functions as assigned by QA/QC manager. 

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

Bachelor's degree (B. A.) in a scientific discipline from four-year college or university; and two to five years related experience and/or training; or equivalent combination of education and experience.

LANGUAGE SKILLS 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 advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. 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 from and deal with several abstract and concrete variable.

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 or 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 employee is occasionally exposed to toxic or caustic chemicals (chemicals used to perform wet chemistry analysis, microbiological testing) and microorganisms (if PPE and procedures are not followed properly). The noise level in the work environment is usually quiet.