QA Technician/Auditor - Rising Pharmaceuticals

Title: QA Technician/Auditor

Role: Full Time / Direct Hire

Location: Decatur, IL, USA

JOB 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.

Must Haves:

• Minimum of 1-2 years of Quality experience.

• Minimum HS/GED required.  Associate degree preferred.   

• Candidates must be able to fulfill physical requirements; regularly required to sit, stand, walk, talk, and hear. 

• Specific vision abilities required by this job include close vision for written work and PC use.  

• Must be able to 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 guidance.

• 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.