Aseptic Filling Technician- 3rd Shift

Kindeva; Brentwood (MO); Sur place; USD 42 000 - 62 000; Plein temps

Résumé du poste

Kindeva is seeking an experienced Aseptic Processing Technician to operate filling machines in a clean room, following cGMP standards and strict documentation practices. You will handle components, verify batch records, and participate in ongoing process improvements.

The role requires ability to work in an aseptic environment, perform gowning procedures, and maintain high safety and quality standards. Training in aseptic techniques and SOPs is essential for success.

Qualifications

• High school diploma or GED or Associate degree is required.
• Experience with aseptic processing and cGMP preferred.
• Ability to read, write and follow SOPs.

Responsabilités

• Follow aseptic/cGMP techniques.
• Operate component assembly machines and filling machines.
• Unload sterilizers and properly handle components.
• Review and perform required accountability, documentation and quality in-process test results per SOP/Batch Record.
• Receive components, verify counts and assign to batches.
• Perform appropriate department housekeeping per SOPs.
• Meet aseptic gowning requirements and adhere to aseptic techniques in Aseptic Processing Area.
• Other duties as assigned.
• Participate in process improvements activities.

Connaissances

Aseptic techniques

Gown certification

Quality documentation

Machinery operation

Safety procedures

SOP reading/compliance

Formation

GED or High School Diploma; Associate degree

Description du poste

ROLESUMMARY

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

ROLERESPONSIBILITIES

• 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 appropriate department housekeeping duties per SOP’s.
• 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.

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.

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

Equal Opportunity Employer:

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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