Aseptic Filling Technician

Kindeva; Maryland Heights (MO); Sur place; USD 42 000 - 54 000; Plein temps

Résumé du poste

Kindeva is seeking a manufacturing technician to work in a sterile, clean room environment following cGMP and aseptic guidelines. You will assemble components, operate filling machines, and ensure strict documentation and batch record accuracy.

Responsibilities include loading components, performing aseptic operations, and maintaining housekeeping and gowning standards to support a compliant production area. Opportunities exist to participate in process improvements and training.

Qualifications

• High school diploma or GED or Associates Degree; one to three months related experience and/or training.

Responsabilités

• Follow aseptic/cGMP techniques.
• Operate component assembly machines and filling machines.
• Unload sterilizers and properly handle components.
• Review and perform as required, proper accountability, documentation and quality in-process test results as required per the applicable SOP or Batch Record (Batch records and logbooks).
• Receive components, verify counts and assign to respective batches.
• Perform aseptic operations.
• Perform appropriate department housekeeping duties per SOPs.
• Continually meet aseptic gowning requirements and adhere to aseptic technique principles at all times inside the Aseptic Processing Area.
• Other duties as assigned.
• Participate in process improvements activities.

Connaissances

Aseptic techniques

cGMP knowledge

Machine operation

Documentation

Quality testing

Formation

High school diploma or GED

Associates Degree

Description du poste

ROLE SUMMARY

Work using Sterile and good cGMP techniques in a Clean Room environment in order to assemble components and operate filling machines.

ROLE RESPONSIBILITIES

1. Follow aseptic/cGMP techniques.
2. Operate component assembly machines and filling machines.
3. Unload sterilizers and properly handle components.
4. Review and perform as required, proper accountability, documentation and quality in-process test results as required per the applicable SOP or Batch Record. (Batch records and logbooks)
5. Receive components, verify counts and assign to respective batches.
6. Perform aseptic operations.
7. Perform appropriate department housekeeping duties per SOP’s.
8. Continually meet aseptic gowning requirements and adhere to aseptic technique principles at all times inside the Aseptic Processing Area.
9. Other duties as assigned.
10. Participate in process improvements activities.

BASIC QUALIFICATIONS

High school diploma or general education degree (GED) or Associates Degree; one to three months related experience and/or training.

TECHNICALQUALIFICATIONS

• To perform thisjob successfully,anindividual mustbe abletoperform eachessential dutysatisfactorily.The requirementslistedbelow arerepresentativeofthe knowledge, skill and/orabilityrequired.Reasonable accommodationsmaybemadetoenable individualswith disabilitiesto perform theessential functions.
• Position requiresbending,stooping, squatting,pull/push andreaching above theshoulder level.
• Abilitytoread andcomprehend simple instructions,correspondence, andmemos.
• Abilityto write correspondence.
• Abilityto effectivelypresentinformation in one-on-oneand small group situationstootheremployeesoftheorganization.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to apply commonsense understanding to carry out instructions furnished in written, oral or diagram form.
• Must be able to pass and maintain Gown Certification requirements in order to perform required tasks.
• All new external applicants will be required to pass an assessment test.

PHYSICAL QUALIFICATIONS

• The physical demandsdescribed herein arerepresentativeof thosethat must bemetbyanemployeeto successfullyperformthe essentialfunctionsof thisjob.
• While performingthedutiesof thisjob,the employeeisregularlyrequiredtouse handstofinger,handle,orfeel objects, tools, or controls.
• The employeeisregularlyrequiredtostand andwalk;climb or balance; and stoop,kneel, crouch, orcrawl.
• The employeemustoccasionallyliftand/or moveupto 40pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral,
• vision, depth perception and the ability to adjust and focus.
• Cannot be claustrophobic.
• Must achieve a score of 9 or above for near vision (14\") with both eyes using a Titmus II vision tester.
• Position requires bending, stooping, squatting, pull/push and reaching above the shoulder level.
• The employee must wear all required safety equipment and perform assigned work in a safe manner.
• Employee must use proper lifting techniques and be conscious of hazards around him/her.
• Must follow all GMP and safety procedures within the department.