Job Summary:
We are seeking a detail-oriented and experienced QA Technician/Auditor to join our team.

Essential Duties & Responsibilities:

Monitor the production process and ensure consistency of procedures.

Perform visual inspection of finished product.

Perform AQL testing of finished product.

Review in process documentation.

Audit manufacturing rooms for adherence to cGMP and SOPs Audit the maintenance of a clean and sanitary environment.

Review daily/weekly/monthly and bi-monthly logbook entries for completeness.

Review, approve and issue verified -clean green release stickers to operations.

Check machine settings.

Observe/mentor personnel on aseptic performance.

Perform line clearances and review documentation (circular charts, autoclave tapes etc.) to allow operations to initiate production (release to fill).

Obtain and maintain gown certification for clean room entry.

Job Prerequisites:

All full-time employees are required to work a 40-hour week.

At times, additional hours during the weekdays, evenings, and/or weekends will be required to complete tasks and meet deadlines.

All applicants must be able to meet the attendance standards.

Must have a complete knowledge of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820), and other FDA regulations and guidance’s.

Have general math skills: adding, subtracting, multiplication, division, and percentage calculation.

Ability to calculate figures and amounts such as discounts, interest, commissions, and proportions.

Able to use personal computer and standard office equipment such as fax and copy machines, calculators, and printers.

Aptitude to learn computer programs as needed (i.e. Microsoft Office Word, Excel) in addition to other business applications.

Strong verbal and written communication skills.

Resourceful and well organized.

Ability to read and interpret standard documents such as: procedure manuals, employee handbook, and job related publications.

Education and Experience:

Associate's Degree or equivalent from a two-year college or technical school;

One year related experience and/or training; or equivalent combination of education and experience.

Job Type: Full-time

Pay: $20.00 - $24.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 5 years
• 6 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person

Ability to Relocate:

• Decatur, IL 62521: Relocate before starting work (Required)

Work Location: In person