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 aseptic operations.
- 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.
TECHNICAL QUALIFICATIONS
- To perform thisjob successfully,anindividual mustbe able toperform 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.
This is a 2nd shift opportunity, 2pm-10:30pm