Clinical Packer Technician (CONVERSION) - 2nd shift
Company: PCI Pharma Services
Posted on: May 4, 2021
Clinical Packaging Technicians are highly skilled personnel that
must rely on human abilities to create packages that are identical
to the other packages within and between the project work orders to
assure clinical supply blinding. Technicians are relied upon to
identify any package characteristics that would unblind the
clinical supply. Due to the nature of the labeling operation the
personnel will be working in a zero defect environment. Machines
may be used with some packaging of primary or secondary packages,
but typically all clinical labeling projects rely on the person's
individual abilities to produce packages that maintain blinding for
- Works in a zero defect environment, ensuring each and every
package meets clinical standards of precision and
- Packages and inspects quality into the product, as machines and
technology are not utilized on every line.
- Can make judgment calls on package assembly and conform to
standards required by the study blinding required in the work
- Ensures work is consistent between work orders to maintain
clinical blinding requirements.
- Proposes creative solutions to problems and resolve issues for
the working requiring zero defects.
- Works effectively in a clinical packaging environment that
utilizes serialized kit numbers, when packaging lot is made up of
multiple individual packaging lots.
- Completes necessary batch record or other work center
documentation by following company documentation techniques. This
typically includes roster, inspection confirmations, or other
documentation as required by the customer and work center.
- PAPR Certification is desirable as many products require PAPR
- Work with frozen and refrigerated products, the Clinical Packer
Technician must be able to handle these products with any required
procedures and gowning as directed by the product
- Determine best pack out for clinical distribution activities
when not called out specifically in the batch record documentation.
This includes making decisions on appropriate shipcase, partitions,
dunnage, as well as how to sequence the kits into the proper order
to ensure ease and accuracy of picking. Complete and manage ship
case identification with clinical sequential and unique kit ID
tags. Determine and follow pattern for storage on appropriate
pallet, cage, cart or other.
- Ensures the quality of products being packaged by inspecting
for defects or problems; making sure the lot code and expiration
date are present as applicable, legible and in the correct
location; ensuring seats meet minimum acceptable standards;
checking for damage to products and packages; making sure the
product is intact and has the appropriate quantity, removing items
with quality issues; and informing the Clinical Technical Leader of
- Performs the hold process for non-compliant products by
inspecting non-conforming packages; reprocessing products after
inspection; and communicating issues to Clinical Technical
- Ensures appropriate job validation by scanning their work order
and badge number; cleaning the equipment and work area; performing
product changeover duties; and attending and participating in
monthly cGMP meetings.
- This position may require overtime and/or weekend
- Knowledge of and adherence to all PCI, cGMP, and GCP policies,
- Attendance to work is an essential function of this
- Performs other duties as assigned by Manager/Supervisor.
- TABE testing requirements met at approved grade level for
- Basic Mathematical Skills
- Minimum Professional Proficiency: Ability to speak in a way
that allows one to participate effectively in various
conversations. Ability to read various types of standard items
addressed to general readers.
- Basic Reasoning: Ability to apply common sense understanding to
carry out uninvolved written or oral instructions. Ability to deal
with problems that involve only a few concrete variables in
- Must be physically capable to perform the above duties with or
without reasonable accommodations.
Equal Opportunity Employer/Vet/Disabled
Keywords: PCI Pharma Services, Rockford , Clinical Packer Technician (CONVERSION) - 2nd shift, Professions , Rockford, Illinois
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