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Manufacturing Associate I - Fill Finish - 2nd Shift

$30.05 - $31.25 per hour

Iviva Medical

divh2Manufacturing Associate I, Fill Finish (2nd Shift)/h2pUnited Therapeutics seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughters pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant./ppAs a Manufacturing Associate I, Fill Finish (2nd Shift), youll play a hands-on role in producing sterile drug products that patients and families depend on. Youll support fill-finish operations by operating equipment, preparing materials, completing cGMP documentation, and maintaining a clean, compliant production environment. This role is ideal for someone who takes pride in precision, follows procedures with care, and enjoys being part of a collaborative manufacturing team where quality and safety come first./ppThe Manufacturing Associate I, Fill Finish (2nd shift) provides process support for the production of drug products under strict adherence to cGMP, OSHA, and United Therapeutics policies and regulations in the Silver Spring, Maryland facility. Assist with operating process equipment under strict adherence to cGMP, OSHA, and United Therapeutics policies and regulations ensuring that the production areas and all equipment are clean and in orderly operating condition. Utilize understanding of equipment to perform basic steps necessary to manufacture. Monitor basic work processes, ensure components, materials and supplies are stocked prior to the start of the filling operations to assure compliance and completion of targets. Provide necessary support for all production activities associated with production work. Receive production raw materials. Perform basic troubleshooting and assist with technical issues. Complete general and triennial basic changes to SOPs and other manufacturing documents within limited scope. Work on basic routine assignments per written procedures and batch records of basic scope with guidance from senior associates. Complete all required documentation for proper traceability of a production lot. Complete all cGMP training documentation within a pre-defined timeframe in order to ensure compliance./ppMinimum Requirements:/pulliH.S. Diploma or General Education Degree (GED)/lili2+ years of experience in cGMP pharmaceutical manufacturing environment with a H.S. Diploma/GED or Associates Degree or 0+ years of experience in cGMP pharmaceutical manufacturing environment with a Bachelors Degree/liliAbility to handle confidential company data, projects, and information/liliAbility to see, discern, and distinguish colors (trichromatic)/liliAbility to interact with other departments effectively/liliAbility to objectively, accurately, and thoroughly convey complex issues in writing/liliProficiency with Microsoft Office or equivalent/liliWritten and verbal communication skills/liliFlexibility to work weekends in rare instances/li/ulpPreferred Qualifications:/pulliAssociates Degree in a scientific discipline or related field or Bachelors Degree in a scientific discipline or related field/lili1+ years of experience in gowning procedures in a cGMP environment/lili1+ years of experience with sterile aseptic fill operations and equipment/lili1+ years of experience with manual / visual inspection of drug product containers/lili1+ years of experience with SAP or similar inventory management system/li/ulpJob Location: United Therapeutics requires this candidate to be 100% on-site at our Silver Spring, Maryland location. This role is expected to work 2nd shift, 230pm-11pm, Monday through Friday. The salary range for this position is $30.05/hr to $31.25/hr and this role will additionally be eligible for 2nd shift pay differential./ppEligible employees may participate in the Companys comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off paid parental leave benefits, disability benefits, and more./p/div

Iviva Medical
Vacancy posted 3 days ago
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