QA Technician/Auditor

POSITION DESCRIPTION

Position Title: QA Technician - Grand Department: Quality Assurance

Reports To: Senior Manager Quality Assurance - Operations Work Location: Decatur, Illinois

Position Summary:

• The QA Technician performs quality assurance duties to prevent or eliminate defects in products for sterile filling operations or in final inspection and packaging operations.
• This individual must work in a detail-oriented, compliant manner in a high-stress environment where adherence to deadlines is critical.
• The individual must display an exemplary level of integrity at all times.
• Manage a workload of varying priorities while adhering to strict deadlines.

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.

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 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 guidances.
• 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.
• Ability to write routine reports and correspondence.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Physical Demands, Mental Requirements, and Work Environment:

• While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear.
• The employee is required to use hands to finger, handle, or feel.
• Specific vision abilities required by this job include close vision for written work and PC use.

Job Type: Full-time

Pay: $31.00 - $34.00 per hour

Expected hours: 40 per week

Benefits:

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

Experience level:

• 7 years

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Associate (Required)

Experience:

• Manufacturing: 7 years (Required)
• CGMP: 7 years (Required)
• pharma: 7 years (Required)

Shift availability:

• Day Shift (Preferred)

Work Location: On the road

Salary : $31 - $34