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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:-
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 computers 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.
Job Type: Full-time
Pay: $30.00 - $33.00 per hour
Schedule:
Experience:
Shift availability:
Work Location: On the road
Full Time
$72k-88k (estimate)
03/31/2024
05/26/2024