Clinical Packer

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Job Title:

Clinical Packer Technician

Department/Group:

Clinical Ops

Locations:

Bridgewater

Reports to:

Operations Supervisor, Clinical

FLSA Status:

Hourly

Summary of Objective:

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 clinical trials.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Works in a zero defect environment, ensuring each and every package meets clinical standards of precision and perfection. 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 order. 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 use. 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 handling. 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 issues. Performs the hold process for non-compliant products by inspecting non-conforming packages; reprocessing products after inspection; and communicating issues to Clinical Technical Leader. 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 work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

• Stationary Position: None

• Move, Traverse: 3/4 of the day and up.

• Operate, activate, use, prepare, inspect, or place: 3/4 of the day and up.

• Install, place, adjust, apply, measure, use, or signal: 3/4 of the day and up.

• Ascend/Descend or Work Atop: 3/4 of the day and up.

• Position self (to) or Move (about or to): 3/4 of the day and up.

• Communicate or exchange information: 3/4 of the day and up.

• Detect, distinguish, or determine: 3/4 of the day and up.

On an average day, the individual can expect to move and/or transport up to 25 pounds

between 1/2 and 3/4 of the day.

This position may have the following special vision requirements.

• Close Vision ☐ Distance Vision ☐ Color Vision ☐ Peripheral Vision ☐ Depth Perception

• Ability to focus ☐ No Special Vision Requirements

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

• Work near moving mechanical parts for 3/4 of the day and up.

The noise level in the work environment is typically, moderate.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Skills testing requirements met at approved grade level for position.

• Basic Mathematical Skills

• None

• 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 standardize situations.

Preferred:

• Ability to follow instructions and respond to management direction.

• Ability to work independently and/or part of a team.

• Ability to demonstrate attention to detail.

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Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.