Inspection and Packaging Operator - 10 Hour Day Shift
Xellia

Cleveland, Ohio

This job has expired.


Would you like to join an award winning organization that is dedicated to saving lives?

In 2019, Xellia Pharmaceuticals was recognized by the Business Culture Awards as an organization that has impacted its culture through transformative initiatives. Focused on building a sustainable environment through company values and a leadership promise to its employees. Our people make us what we are. We aim to attract the most talented, passionate employees in our industry and to earn their loyalty and commitment.

We support our employees through comprehensive people resources processes ensuring that every employee is treated fairly and has a voice which is listened to and valued.

Is that you? If so, we want to learn more about you!

Position Summary:

An Inspection and Packaging Operator is responsible for execution of all aspects of theIV bag inspection and packaging process which includes, but not limited to, the manualinspection of safe and effective sterile (injectable) pharmaceutical products. Operationof secondary packaging line equipment, labelling, and equipment cleaning. Interactswith Quality, Technical Services, Maintenance, Warehouse Departments, and otherdepartments as required.Ensures that daily production is carried out according to current SOP's ensuringabsolute compliance to quality standards. The Operator is responsible for documentingdaily production outputs and efficiencies and keeps other stakeholders involved andinformed. Challenges during production are documented and resolved by means ofvarious LEAN tools. Collaborates in the training of colleagues.

Key Responsibilities:

Set-up, operation, and troubleshooting of manufacturing equipment: including (butnot limited to) Manual Inspection Booths, Semi-Automated Inspection Machine,Secondary Packaging Machines and ancillary equipment (conveyors, pallet jacks,

etc.) within validated parameters and in compliance with cGMP's.

Operation of automated equipment through a Human Machine Interface (HMI).

Clear and concise written documentation to support GMP activities.

Performs line change overs and simple-to-moderate equipment adjustments.

Supports the creation and updating of procedures enabling the improvement of

quality, compliance, and overall process performance.

React to issues on the production line and start up systematic problem-solvingenabling colleagues to support root cause analysis.

JOB DESCRIPTION

  • Adhere to cGMP's, SOP's, Batch Record processing steps, and site environmental
  • and safety policies.
  • Support a continuous improvement culture and mind set within the department.
  • Possess strong commitment to quality and compliance. Guide colleagues in the
  • importance of proactive behavior regarding improving the work environment towards
  • zero accidents.
  • Work closely together with quality to solve quality issues as they occur and ensuretimely release of products.
  • Responsible for execution and completion of individual Training per requiredcurriculum.
  • Ensure processes and products are in compliance with all local, state, and federalrules and regulations.
  • Oversee that processes are in CGMP compliance, andestablish systems that identifies opportunities for improvement and makesconstructive suggestions for change to improve process effectiveness to heightenquality.
  • Develop knowledge of and understand regulatory requirements such as21CFR Parts 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies.

Requirements:
  • High School Diploma or GED; Associates Degree in a natural science or technicalcurriculum preferred
  • Prior experience in a regulated environment; Pharmaceutical or medical devicemanufacturing experience preferred
  • Must be able to learn and develop a working knowledge of cGMP's; previousknowledge of cGMP requirements preferred
  • Prior experience with complex high speed packaging equipment
  • Experience with quality control technology including vision, robots or automationpreferred
  • Ability to clearly read and write English
  • Demonstrates a strong desire to continuously learn and improve

Physical Requirements of the Role:
  • Adequate vision required, must be able to successfully pass visual acuity requirements(20/20 corrected vision, distinguish colors as required.
  • Visual Acuity requirements are tested annually).

JOB DESCRIPTION
  • Ability to stand, sit, and/or walk for long period of time. Ability to operate materialhandling equipment.
  • Ability to lift, push, and/or pull up to 50 lbs frequently.
  • Position requires continuous standing and walking.
  • Must be able to be gown qualified.
  • Any person shown at any time (either by medical examination or supervisoryobservation) to have an apparent illness or open lesions that may affect the safety orquality of a drug product shall be excluded from direct contact with components, drugproduct containers, closures, in-process materials, and drug products until the conditionis corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products.
  • All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.
  • This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
  • The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
  • Employees holding this position will be required to perform any other job-related duties as requested bymanagement.
  • All requirements are subject to possible modification to reasonably accommodateindividuals with a disability.

Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company's evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.
Further information about Xellia can be found at: www.xellia.com
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