U-09 Aseptic Production Support Operator

Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

ROLE RESPONSIBILITIES

• Must be able to understand, follow, and operate applicable SOP’s and batch records for but not limited to, this equipment; i.e. Autoclaves, Gruenberg Oven, Crest Ultrasonic Cleaner, Huber washer, Capsolut, Drum Roller, and Bausch & Stroebel Washer,
• Properly document all required entries on of batch records, logbooks and sterilization records including proper performance and documentation of in-process checks.
• Properly perform and document verification of other technicians on batch records and sterilization records.
• Properly clean equipment as well as perform and document line clearances.
• Receive components, verify counts, and assign to batches.
• Be knowledgeable cGMP’s as related to the above tasks.
• Perform special projects as directed by the Supervisor.
• Must be able to consistently follow all required environmental control procedures (example: glove changes, donning of designated coveralls and head covers, handling of components under laminar flow hoods, etc…
• Must be able to perform cleaning of department including overhead work.
• Other duties as assigned
• Participate in process improvement activities.

BASIC QUALIFICATIONS
High school diploma / general education degree (GED) or an Associate’s degree plus 1 year Manufacturing / Packaging work experience or Veterans/Military
TECHNICAL QUALIFICATIONS

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Ability to read and comprehend simple instructions, correspondence, and memos.
• Ability to write correspondence.
• Ability to effectively present information in one-on-one and small group situations to other employees of the organization.
• 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.
• All new external applicants will be required to pass an assessment test.

PHYSICAL QUALIFICATIONS

• The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls.
• The employee is regularly required to stand and walk; climb or balance; and stoop, kneel, crouch, or crawl.
• The employee must occasionally lift and/or move up to 40 pounds.
• 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.
• Position requires bending, stooping, squatting, pull/push and reaching above the shoulder level.

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