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Service Operator - Buffer/Formulation Level 1

Alphanumeric Systems, Inc. Marietta, PA
  • Expired: 21 days ago. Applications are no longer accepted.
Alphanumeric is hiring a SERVICE OPERATOR
- BUFFER/FORMULATION Level 1 to work in Marietta, PA with one of the largest pharmaceutical companies in the world.
This position will use proper aseptic technique while performing tasks in the Grade A/B areas to include: bulk formulation, vial filling, routine and non
-routine aseptic interventions; operating filling and auto loading equipment using automated control systems, unloading of autoclaves and management of sterilized components.


Key :




-Operate processing equipment in accordance with SOPs, in all classified areas (Grade A/B/C).

-Actively participate in troubleshooting processes and equipment problems as well as assisting the supervisor in completing all necessary paperwork associated with investigations, deviations and remarks.

-Use proper aseptic technique while performing tasks in the Grade A/B areas to include: filling line, routine aseptic interventions (pulling of samples, EM monitoring & clearing downed vials), non
-routine aseptic interventions (filler setup, needle changeout), operating filling and auto loading equipment using automated control systems; perform automatic weight checks; assist with and performs non
-routine interventions without compromising aseptic environment.

-Actively participate in the creation and revision of batch records, standard operating procedures, protocols, and all other GMP documents.

-Troubleshoot process equipment and interact with maintenance personnel

-Demonstrate proficiency as outlined in training requirements for equipment systems and position.

-Responsible for loading and unloading materials, labeling according to SOPs, assembling valves, connectors, and other equipment and tools using Aseptic technique.

-Recognize and report deviations or potential issues immediately to the management team.

-Perform all job responsibilities in compliance with applicable regulations, guidelines, policies, standard operating procedures, and industry practice and Industrial Excellence initiatives.

-Communicate and report status of equipment maintenance related issues to the area supervisor / manager, and assist with actions necessary to resolve issues.

-Work on any assignment as directed.

-Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, standard operating & safety procedures, and industry practice and Industrial Excellence initiatives.




Key Skills/Education/Experience:


-BS or BA in a biological, chemical science, engineering or degree in other discipline if sufficient technical depth has been achieved from professional experience. In lieu of degree, candidates with sufficient technical depth achieved from professional experience in an Aseptic environment may be considered.

-Previous manufacturing or laboratory experience requiring aseptic or sterile technique required.

-Some mechanical aptitude required in order to operate pumps, scales and PH meters.

-The capability to maintain attention to detail and quality and a high level of integrity and confidentiality, while completing multiple or repetitive tasks and meeting timelines and deadlines.

-Ability to read, understand, follow and comply with technical and written documents (SOPs.)

-Ability to work around acids, bases, oxidizers and cleaning solvents while wearing appropriate PPE.

-Ability to perform calculations using simple mathematical formulas using fractions, percentages and significant numbers. The ability to measure volume and weight.

-Must be able to follow detailed processing instructions as well as clearly and accurately documenting all necessary batch documentation.

-Basic computer skills required

-Ability to complete and maintain Aseptic gowning requirements. Must be able to work while wearing full protective gowning required for GMP areas for an entire shift.

-

-Physical requirements include stooping, standing, climbing and lifting of between 30
- 50 lbs.

-Ability to establish and maintain working relationships cross functionally including production, QA, QC, engineering, validation, and maintenance.

-The ability to communicate effectively, both verbally and in writing, to all levels within the organization.

-Position may require employees to work in a 24/7 rotational schedule. This schedule will include holidays, and weekends; over
-time may be required. Work closely with shift team to achieve goals in a 24/7 cGMP Production Environment.

-Must be available to work ANY of the following shifts
- :

-
1st shift = 6:00 am
-4:30 pm Tuesday, Wednesday, Thursday, Friday (10 hr days)
2nd shift
- 2:00 pm
- 12:30 am Tuesday, Wednesday, Thursday, Friday (10 hr days)
3rd shift = 10:00 pm
- 8:30 am Tuesday, Wednesday, Thursday, Friday (10 hr days, shift ends Saturday morning)
4th shift = 7:00 am
- 7:30 pm Saturday, Sunday, Monday (12 hr days)
5th shift = 7:00 pm
- 7:30 am, Saturday, Sunday, Monday (12 hr days, shift ends Tuesday morning)

Alphanumeric Systems, Inc.

Why Work Here?

Contract to hire

At Alphanumeric, we believe that no matter how great your vision, it's your people—customers and employees—that will it a reality. Since 1979 we've helped our pharma, healthcare, public sector, and finance clients realize their vision by removing the friction from customer and employee experience. Our large-scale contact centers feature artificial intelligence and deep expertise—achieving customer satisfaction ratings upwards of 95 percent. We offer fully managed technology modernization, security, and support across your entire workforce. When it comes to employees, we know that technology and operations are only half of the story; our learning solutions help you swiftly and effectively on-board, ensure compliance, and transform your workforce. Improving people experience is what we do, but the thing that really gets us fired up is our relationship with our customers.

Address

Marietta, PA
USA

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