*Must haves: *
Minimum of 5-6yrs of Quality experience.
Minimum HS/GED required.
Associate degree preferred.
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.
*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.
*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 Type: Full-time
Pay: $40,000.
00 - $46,000.
00 per year
Benefits:
* Employee discount
* Life insurance
* Referral program
Schedule:
* Monday to Friday
Education:
* High school or equivalent (Required)
Experience:
* Audit manufacturing: 5 years (Required)
Work Location: In person
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