U-09 Aseptic Production Support Operator

Kindeva; Brentwood (MO); On-site; USD 22,000 - 30,000; Full time

Job summary

Kindeva is hiring Clean & Prep Technicians to join the STL-Brentwood team. The role requires following SOPs, batch records, and cGMP practices while maintaining clean room standards and performing line clearances.

The position involves handling components, documenting inspections, and supporting process improvements in a manufacturing setting. A high school diploma or GED with some manufacturing experience is required.

Qualifications

• High school diploma/GED or an Associate’s degree with 1 year manufacturing/packaging experience or military
• Ability to read and comprehend simple instructions, correspondence, and memos.
• Ability to write correspondence.
• Ability to present information clearly in small groups.
• Math skills: add, subtract, multiply, and divide with standard measures.
• Ability to follow written, oral, or diagrammed instructions.
• All new external applicants will be required to pass an assessment test.

Responsibilities

• Follow SOPs and batch records for equipment and sterilization processes.
• Document batch records, logbooks and sterilization records.
• Verify and document verification of other technicians’ records.
• Perform cleaning and line clearances of equipment and area.
• Receive components, verify counts, and assign to batches.
• Adhere to cGMP and environmental control procedures.
• Participate in process improvement activities.

Skills

Reading instructions

Writing correspondence

Mathematical ability

Attention to detail

Communication

Ability to follow SOPs

Team collaboration

Education

High school diploma or GED

Associate’s degree

Job description

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.

Ready to work with purpose? Look no further, we are hiring for passionate Clean & Prep Techs to join our STL- Brentwood team.

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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