Aseptic Filling Technician- 1st, 2nd and 3rd shift Available

Kindeva; Brentwood (MO); On-site; USD 42,000 - 64,000; Full time

Job summary

Kindeva seeks an operator to work in a sterile, compliant clean room environment, assembling components and operating filling machines. You will follow aseptic techniques, manage components, and document batch records to ensure quality in-process results.

The role requires the ability to pass gowning certification, perform basic math, and adhere to SOPs. This is a hands-on position in a GMP setting with potential process improvements.

Qualifications

• High school diploma, GED or Associate degree; 1–3 months related experience.
• Must pass and maintain Gown Certification.
• Able to stand, walk, lift up to 40 pounds and follow SOPs.

Responsibilities

• Follow aseptic/cGMP techniques.
• Operate component assembly and filling machines.
• Unload sterilizers and handle components.
• Review and document batch records and in-process test results as per SOPs.
• Receive components, verify counts and assign to batches.
• Perform aseptic operations.
• Maintain department housekeeping per SOPs.
• Meet aseptic gowning requirements and follow aseptic principles in Aseptic Processing Area.
• Take part in process improvements.

Skills

Gowning and aseptic technique

Aseptic handling

Quality documentation

Basic math and measurement

Reading instructions

Written communication

Gown Certification

Education

High school diploma or GED or Associate degree

Job description

ROLESUMMARY

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

ROLERESPONSIBILITIES

• Followaseptic/cGMP techniques.
• Operatecomponent assembly machines and filling machines.
• Unloadsterilizers and properly handle components.
• Reviewand 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)
• Receivecomponents, verify counts and assign to respective batches.
• Perform asepticoperations.
• Perform appropriatedepartment housekeeping duties per SOP’s.
• Continuallymeet asepticgowningrequirements and adhere to aseptic technique principles at all times inside the Aseptic Processing Area.
• Otherdutiesasassigned.
• Participatein process improvements activities.

BASICQUALIFICATIONS

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.

PHYSICALQUALIFICATIONS

• 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.