Quality Assurance Analyst

The Sunrider Corporation; Town of Texas (WI); On-site; USD 55,000 - 75,000; Full time

Job summary

The Sunrider Corporation is looking for a QA/QC professional to support internal audits, document control, and investigations of quality issues within a dietary supplement manufacturing context.

You will review batch records, support CAPA activities, training records, and assist with external audits such as FDA, ISO, Kosher and Halal compliance.

Qualifications

• Bachelor's degree in a scientific discipline required.
• 2+ years of QA/QC experience preferred.
• Experience with batch record review and CAPA desirable.
• Exposure to food/dietary supplement manufacturing is a plus.

Responsibilities

• Administer change control on SOPs, batch records, and regulatory procedures.
• Review production paperwork, batch records, QC inspections and sanitation reports for accuracy and completeness.
• Conduct monthly internal GMP audits and generate GMP reports.
• Prepare Rework, Deviation, OOS, and NCMR documentation.
• Assist with investigations of product failures, customer complaints, and CAPA.
• Coordinate training programs and maintain training records.
• Assist with supplier qualification package reviews.
• Support calibration and maintenance program for equipment and instruments.
• Maintain records of environmental and pest control programs.
• Report quality trends to QA/QC management and participate in investigations.
• Assist with preparation for FDA, NSF, ISO, Kosher, Halal, and other external audits.

Skills

Quality Assurance

Quality Control

Internal Audits

Documentation control

CAPA investigations

FDA/ISO readiness

Education

Bachelor's degree in science

2+ years QA/QC experience

Tools

MS Excel

Database software

Word processing

Job description

Job Description

Job Description

SUMMARY

Conducts internal audits, performs documentation control and reviews, helps investigate, and resolves quality issues, deviations, and customer complaints. Files, updates and creates QC, production and training records.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Includes the following, but other duties may be assigned as Sunrider’s needs dictate:

• Administer the change control on company documents (SOPs), manufacturing (batch records) and regulatory procedures and ensure that appropriate training is documented and only the most current revisions are in use.
• Reviews and audits production paperwork, batch records, QC inspections and sanitation reports for accuracy and completeness, calculates production yield and ensures compliance with established specification limits.
• When necessary, perform Monthly Internal GMP audits for all company departments, including production, R&D, maintenance, etc. and generate monthly GMP reports.
• Prepare Rework, Deviation, OOS, and NCMR documentation.
• Assists with the investigation of product failure, customer complaints, and CAPA. Maintain Customer Complaint and Material Non-Conformance files.
• Help coordinate employees' training programs and oversee the completeness of employees' training records.
• Assist with material supplier qualification package reviews.
• Help with the equipment and instruments, calibration, and preventive maintenance program.
• Assists in maintaining records of the environmental and pest control programs.
• Reports quality and/or food safety trends and potential issues to Quality management and participates in investigations as necessary.
• Promotes GMP, GDP, Food Safety, FDA’s and company policies within QA/QC and production departments.
• Assists with preparation for FDA, NSF, ISO, Kosher, Halal, and other external audits.
• Other tasks and functions as assigned by the 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 accommodation 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. Shall have 2 + years of experience in Quality Assurance or Quality Control. Experience with batch record review, CAPA and customer complaints investigation, deviation and rework procedures are much desired. Shall have some experience working on the floor of a food/dietary supplement manufacturing facility. High school diploma could be acceptable accompanied with 7+ years relevant work experience and/or training.

LANGUAGE SKILLS

Ability to write reports, business correspondence, and procedure manuals. Ability to read, analyze, and interpret technical procedures, and/or government regulations. Ability to effectively present information and respond to questions from departmental manager/supervisor or other employees.

Employee Job Description

Form: JD TXP0.1 Rev. C 7/1/2023 DD-G-061 Page 2 of 2

MATHEMATICAL SKILLS

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percentage.

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 apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several abstract and concrete variables in standardized situations.

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 accommodation 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 focu