Trains on policies, protocols and procedures as needed to support ability to execute assigned duties.
Performs a wide variety of production operations such as material handling, weighing, mixing, coating, slitting, packaging, cleaning/sanitization, etc.
Performs in-process sampling, inspection and testing as directed.
Executes assigned responsibilities as directed and according to documented procedures (Quality Procedures, Manufacturing Procedures, Batch Records, etc.), protocols, planned deviations, and training lessons. Understands and complies with Pharmaceutical Manufacturing cGMPs consistent with 21-CFR-211 guidelines.
Accurately and thoroughly fills out process-related paperwork (e.g. batch records) and operational documentation.
Seeks Lead and/or Supervisory assistance for clarification in the event of any uncertainties or unexpected occurrences.
Works safely; efficiently organizes work activity maintaining work flow and ensure availability and use of proper materials and tools. Supports LEAN 6S activities as requested.
Accurately fills out all GMP paperwork (e.g. cleaning records, batch records) in a timely manner.
Complies with company policies, good housekeeping, and safety regulations.Maintains a safe and clean work environment; identifies and corrects unsafe practices, conditions, or acts.
Effectively and respectfully interacts and communicates with other operators, associates, and supervisors; relays information to the next shift when applicable; voluntarily assist others where appropriate.
Responsible for following all applicable waste handling procedures.
Additional Responsibilities:
Performs other duties and responsibilities as assigned.
Assisting in deviation investigations.
Preventative maintenance.
Supporting laboratory (Quality, R&D) activities.
Responsible for the proper disposal of hazardous waste into the proper labeled containers and drums.
Making improvement suggestions; providing feedback on procedures and practices.
Job Specifications:
Requires minimum of a high school education - some college and cGMP, CFR211 compliant manufacturing environment experience preferred.
Capable of performing duties involving related steps, processes, and methods.
Ability to comprehend and reliably follow written procedures (batch records, operating procedures, protocols, etc.) and verbal instructions. Attentive to details and capable of error-free procedural implementation.
Ability to work with numbers consistently and accurately; able to accurately read, perform numerical calculations and document numbers. Ability to calculate and round to required significant figures. Ability to perform basic mathematical functions and apply basic statistical concepts such as mean (average).
Ability to maintain flexibility in schedule and routine in response to production schedules changes.
Ability to wear proper PPE for extended periods of time. Minimally safety glasses, sleeve covers, and gloves. At times, uses of additional PPE including masks covering mouth and nose for extended periods of time are required.
Work environment involves moderate risks or discomforts requiring special safety precautions, e.g., working around moving parts, machines, and irritant chemicals; will be required to use personal protective equipment such as masks, gowning, hairnets, gloves, safety glasses/goggles, shields, etc..
Physical exertion such as long periods of standing, recurring bending, crouching, stooping, stretching, reaching, or similar activities should be expected; recurring lifting of moderately heavy items (objects 50 - 100 pounds); constant manipulation of utensils for weighing of components, requires common physical characteristics and abilities, such as above-average agility and dexterity.
Primary contacts are with associates within manufacturing, however, some contact can also be expected with individuals or groups from other internal functions.