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General Manufacturing Operator

Posted 23 days ago

  • Expiry Date: 02 June 2022
  • Referral:

Job Description:

Purpose and Scope of Position:

  • The Operator I is responsible for executing production activities required to successfully manufacture sterile injectable products.

  • This is accomplished by ensuring equipment, materials, and other resources are in place to meet production demands.

  • The Operator I demonstrates and assures production activities within manufacturing operations are executed following all GMPs.

  • In addition, work will be performed in complete accordance with all SOPs, Specifications, Batch Records, regulatory expectations, and company policies.

  • This position will require overtime, shift work, and flexibility in scheduling of set shift hours at times, based on production demands or extraordinary circumstances.

Required Competencies:

  • Knowledge, Skills, and Abilities

  • Robust functionality in Microsoft Applications and other computer based systems utilized in the manufacturing department (i.e. MES, HMIs, etc.).

  • Demonstrated proficiency in the ability to gown into applicable controlled areas per area classification specific requirements.

  • Intermediate written and verbal communication skills within the department and with support groups.

  • Functional job specific proficiency in mathematics.

  • Practical understanding of specialized manufacturing equipment operational theory used for the manufacturing of sterile injectable products.

  • Ability to pass a full physical including a respiratory certification with annual monitoring.

  • Ability to stand up to 8 hrs/day, utilizing controlled movements.

  • Aptitude to use hand tools in the setup and trouble-shooting of specialized manufacturing equipment.

  • Ability to execute complex activities both independently and in a team environment.

  • Duties and Responsibilities:

  • Accomplishes manufacturing activities per detailed procedural guidance with a demonstrated attention to detail.

  • Performs handling of hazardous materials in compliance with site, industry, local, and federal regulations.

  • Maintains manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.

  • Executes specialized responsibilities mandated by detailed written procedures, site, industry, local, and federal regulations.

  • Assures and completes detailed documentation that is a correct and accurate record.

  • Addresses procedural /documentation errors expeditiously and effectively.

  • Continuously updates job knowledge by participating in job specialized training requirements.

  • Participates as a contributing member in CI projects.

  • Consistently projects a positive attitude and example for other department team members/operators to emulate.

  • Performs other tasks as assigned.

Education and Experience:

  • High school diploma or equivalent required.

  • 1 year of relevant work experience required, preferably in a regulated and/or pharmaceutical environment.

  • An equivalent combination of education/experience may substitute.

Working Conditions:

  • Full face respirator may be required for certain activities.

  • The incumbent will be required to push, pull, reach, balance, and/or lift greater than 20 lbs. for 8 hours, approximately 5 times per week.

  • The incumbent may be working around hazardous materials to include chemical agents at least 8 hours per day.

  • The incumbent may be in a standing position for at least 8 hours per day.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.