JOB REQUIREMENTS: Duties and Responsibilties of Job: The Chemical
Packaging Coordinator - 2nd Shift will lead, coordinate, and participate
in all aspects of filling, capping, torquing, and labeling of products
done in an ISO 13485 environment. The Packaging Team Lead will be
expected to complete appropriate packaging documentation per FDA, ISO,
and GMP procedures and deliver products into inventory. Job duties
include: 2nd Shift: Monday - Friday, 2:00pm - 10:30pmOversee packaging
operations ranging from large scale bulk pumping and transfer to small
scale bench top filling with a pipette. Many products will require
filtration and aseptic handling techniquesProvide guidance, instruction,
and feedback to packaging operators performing daily workPlay a key role
in the training and development of packaging staffWork with packaging
team and manufacturing to ensure time-sensitive make/fills and other key
priority products are completed on timeAssist with planning the daily
schedule when necessarySupport the daily management system (D MS) to
ensure key performance targets are metEnsure documentation is accurate
and timelyPerform SAP transactions as needed to keep orders
movingUtilize expertise in manual and automated packaging to help
troubleshoot equipment and processesSupport site quality system by
assisting with deviation and complaint investigations, change control,
and document updatesLead and champion automation and operational
excellence projects to enhance the safety, quality, and productivity of
the packaging operationAssist in interviewing and selecting new
packaging operatorsProvide recommendations for capital expense
requestsAssist in performing instrument qualifications, operation
qualifications, and validationsBe actively involved in technical support
for evaluating business development opportunitiesAlways follow safety
proceduresDocument all equipment used and verify calibration statusWhen
applicable, utilize computerized data collection system to generate fill
line report for batch recordEnsure tim ely and accurate documentation of
all line operationsOversee compilation of batch records and all
ancillary documentationDon, doff, use, and clean PPEBe familiar with
hazards common to assigned work and take action to correct unsafe
situationsParticipate in required safety activities such as training
sessions, meetings, and safety inspectionsDevelop and assist in the
implementation of process improvement ideasComply with the requirements
of ISO 13485 and ISO 9001Participate in 6S activitiesMaintain good
housekeeping and audit readinessAssist in performing instrument
qualifications, operation qualifications, and validationsAssist in
writing and updating equipment specific OPs. Strategic Impact Scope of
People ResponsibilityProvide on-the-floor guidance and feedback to
packaging operatorsContribute to the interviewing and selection of new
packaging employees Physical Attributes: Lift up to 50 pounds Who You
Are: Minimum Qualifications: High School Diploma or GED3 + years of
chemical weighing, laboratory, filling, or packaging experience
Preferred Qualifications: College course in chemistry, other science
experience or 12 months experience weighing chemicals Experience leading
teams or projectsEffective written and verbal communication skillsStrong
knowledge of and ability to troubleshoot automated and semi-automated
filling, capping, and labeling equipmentDemonstrated leadership skills
with ability to guide, train, and coach co-workersUnderstanding of safe
chemical handling practices and methodsGood time management and
organizational skillsHigh understanding of ISO and GMP
requirementsStrong computer skills including SAP and Microsoft
OfficeMechanical skills with ability to use pumps, electronic balances,
and material handling equipmentExperience leading lean manufacturing or
operational excellence projectsStrong math skills including metrics and
conversionsGood grasp of RCA and CAPAProblem solving skillsRSREMD
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