QA Technician – Grand

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 operation 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 exemplary level of integrity at all times.
• Manage a workload of varying priorities while adhering to strict deadlines.

Essential Duties and 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:
• Associates Degree or equivalent from a two- year college or technical school; or one year related experience and/or training; or equivalent combination of education and experience.

Job Prerequisites:
• Ability to meet attendance standards. All full-time employees are required to work a minimum 40-hour week. At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines.
• 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.

Mental Requirements:
• Ability to write, read, and apply technical scientific writing, procedures, and quality policies.
• Ability to work independently in an efficient and detail-oriented manner.
• Ability to work on multiple projects and priorities in a concurrent manner.
• Ability to work in an independent manner, as well as a group environment.
• Ability to apply deductive reasoning and analytical thought to understand complicated issues.
• Ability to receive instructions and follow work rules and company policies.
• Ability to follow safety and security practices.
• Ability to meet deadlines and effectively deal with a high level of office stress.
• Ability to maintain confidentiality of work assignments and personnel issues.

Safety Requirements:
• Safety glasses, close-toed shoes, and latex gloves are required in many areas within the facility
• The list under Essential Functions and Additional Responsibilities is not exhaustive, but merely the most accurate list for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change. This position description in no way states or implies that the responsibilities and tasks are the only responsibilities and tasks to be performed by the employee occupying this position. She/He will be required to follow any other instructions and to perform any other job-related duties as required by his/her supervisor/manager. Requirements stated are minimum levels of knowledge, skills and/or abilities to qualify for this position. To perform the duties and responsibilities of this position successfully, employee will possess the abilities and aptitudes to perform each task proficiently. Employment decisions, including promotions, transfers and others, are based on meeting all requirements and on organizational needs, the employee being in good standing (including lack of disciplinary actions), meeting all applicable performance standards and other non-discriminatory criteria. The methods of fulfilling requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN “AT WILL” EMPLOYMENT.

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