Excipient Operator

Avantor
Aurora, OH Full Time
POSTED ON 9/11/2022 CLOSED ON 10/31/2022

What are the responsibilities and job description for the Excipient Operator position at Avantor?

Job Summary

To safely prepare, set-up, weigh, package, fill and label dry and liquid products for the biopharmaceutical, pharmaceutical and related customer segments to follow and comply with defined procedures/regulatory requirements. Assemble and operate automated/semi-automated equipment while following defined safety policies.

MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)

  • Understand and maintain knowledge and training for the handling of products for the pharmaceutical, biopharmaceutical customer segments to meet established requirements including Regulatory/Quality standards, pharmaceutical customer standards, and corporate requirements.
  • Perform manufacturing and assembly of products in accordance to written production records while observing appropriate safety guidelines.
  • Operate semi-automated and automated filling equipment.
  • Weigh, measure and verify raw materials to assure final packaging contains the proper material and quantities.
  • Complete all assigned work orders, both hazardous and non-hazardous in nature, in the required standard time.
  • Use hand skid and counter balance as necessary to move and position equipment and materials; use care to lift and balance loads properly; operate equipment in a safe manner.
  • Maintains safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures; complying with legal regulations; utilizing proper personal protective equipment.Utilize Safety Data Sheets (SDS) and Material Handling Sheets consistently when coming in contact with chemical material.
  • Exercise proper care in the use of tools, equipment and materials verifying all calibration and verification checks, cleaning as required and maintaining a clean work environment.
  • Process assigned orders per manufactured order, efficiently, error-free and in compliance with safety, FDA/ISO and EXCiPACT guidelines.
  • Verify labels of all materials used in the manufacturing process and dispose of labelled containers as instructed and controlled by Quality Assurance.
  • Maintain equipment and rooms in proper operation condition by following daily cleaning requirements.
  • Perform activities in controlled environment, while assuring the use of appropriate PPE equipment.
  • Complete required reports and records including but not limited to area cleaning logs, equipment logs and balance logs.
  • Detect and report faulty equipment, suspicious materials, improper operations, and unusual conditions to the appropriate individuals.
  • Write and revise Standard Operating Procedures (work instructions) and Filling, Labelling & Assembly Instructions as necessary also developing, maintaining and reporting key departmental metrics while organizing maintaining and purchasing supplies, PPE & other as necessary.
  • Updates job knowledge by participating in training opportunities, attending relevant continuing education classes/seminars.
  • Accepts ownership for accomplishing new and different requests.
  • Explores opportunities and takes initiative to add value to job accomplishments.
  • Performs other duties as assigned.

QUALIFICATIONS (Education/Training, Experience and Certifications)

  • High school completion or equivalent (GED); Associate’s degree preferred
  • 2-4 years related experience and/or training or equivalent combination of education/experience
  • Experience in the pharmaceutical, industrial chemical, medical, lab, life sciences (preferred) or other technical operations environment

KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)

  • Ability to understand Quality Management System and standard documents/requirements
  • Some experience using office or business–related computer applications highly desirable
  • Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume; ability to complete metric conversions
  • Ability to evaluate internal customer needs, and respond with appropriate action/ delivery
  • Speaks clearly and persuasively in all situations listening without interruption remaining open, actively participates in gatherings such as team meetings, and is able to comprehend and create effective written communications
  • Effectively trains others, particularly new employees, to meet complex quality and operating instructions and requirements
  • Understands the requirements of ISO, FDA, EXCiPACT and other such standards

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)

The work environment characteristics and physical effort described here are representative of those an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the associate is exposed to a manufacturing environment. The associate works near moving mechanical machinery and noise level in the work environment is usually loud. The employee will be frequently exposed to moving mechanical parts, fumes and/or airborne particles and is occasionally exposed to toxic or caustic chemicals. The employee must occasionally wear a respirator.

The employee is regularly required to stand, walk, manipulate objects with hands, reach out, speak, listen and sometimes use their sense of taste or smell. The employee is occasionally required to sit, climb, balance, stoop, kneel, crouch or crawl. Furthermore, the job requires associates to lift/carry up to 50 pounds and push/pull up to 100 pounds with or without assistance.

DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Avantor is proud to be an equal opportunity employer.

EEO Statement:

We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at recruiting@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision using the links below.

EEO is the Law

OFCCP EEO Supplement

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

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