Formulation Technician II

Work Schedule

Rotational shift nights/weekends

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team and help us make meaningful contributions to the world. 

       The incumbent will perform various tasks and activities listed below for which they are appropriately trained and are in compliance with the cGMP, company and department SOPs and the safety regulations.  

Responsibilities

• To perform visual inspection of pharmaceutical products to ensure that only products meeting quality, safety, and regulatory requirements are released, by identifying and rejecting units with visual defects in accordance with approved procedures and GMP standards.
• Perform manual and/or automated visual inspection of finished or in-process pharmaceutical products (e.g. vials, syringes, bottles) and
  • Inspect for defects such as:
  • Particulates (visible and non-visible)
  • Cracks, chips, leaks
  • Cosmetic defects
  • Fill volume abnormalities
  • Labeling and container integrity issues

• Accurate record inspection results in batch records, logbooks, or electronic systems.
• Ensure data integrity by completing records legibly, contemporaneously, and accurately.
• Support investigations by providing inspection data and observations when required.

• Perform basic inspection equipment checks and line clerance prior to use.
• Maintain cleanliness and organization of inspection area.
• Report equipment malfunctions or environmental issues promptly.
• Responsible for packaging and transfer of the final product to Freezer.
• Always complete all the relevant training before performing any task.
• Strictly follow aseptic techniques and practices for aseptic operations.
• Carry out the cleaning and upkeep of the production equipment and classified areas in manufacturing area.
• Timely completion of relevant batch record and logbooks for the tasks performed and with adherence to GDP (Good Documentation Practice).
• Transfer materials for manufacturing a batch.
• Provide for the loading/unloading of the loads/batch from the equipment during production activities.
• Perform stock check of consumables and inform Manager/Lead technician for required materials.
• Follow safety and quality compliance at all times and communicate in a timely manner to the manager if any anomalies are observed.
• Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable.
• Perform all tasks in accordance with the standard operating procedures and maintain strict compliance to GMP at all times. Report all the quality issues immediately to Manager or Lead technician.
• Conduct in-process inspection and checks.
• Any other duties as and when assigned by the Manager.

Education

• Minimum “O” Level, NITEC/ITE education.

Experience

• Prior experience in pharmaceutical manufacturing or visual inspection is an advantage.

Knowledge, Skills, Abilities

• Good visual acuity and color vision (must pass periodic eye tests).
• Basic understanding of GMP and data integrity principles.
• Ability to work independently and in a team.
• Able to work as a team.
• Willingness to perform repetitive tasks for extended periods.
• Ability to sit or stand for prolonged periods.
• Ability to perform repetitive visual tasks with sustained focus.
• Willingness to work shifts, if required.