What are the responsibilities and job description for the ARx Packaging Operator l - Temporary Assignment position at ARx, LLC?
Job Summary:
Responsible for assisting in packaging, developing, scaling up and validating processes used for producing specialty drug delivery products in a manner compliant with 21CFR211 and all other relevant regulatory requirements on the ARx packaging lines.
Performs production operations as directed to support developmental and commercial business needs. Complies with all established regulatory and company guidelines and procedures.
ARx Operator G8 is an entry level position defined as having been in the ARx Operations/Packaging department for less than 2 years and having been trained in either the primary packaging or secondary packaging process of the packaging department.
Essential Functions:
- Trains on policies, protocols and procedures as needed to support ability to execute assigned duties.
- Performs a wide variety of packaging operations such as primary packaging, secondary packaging, material handling, 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 Technical Operator and/or Supervisory assistance for clarification in the event of any uncertainties or unexpected occurrences.
- Works safely; efficiently organizes work activity maintaining workflow 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.
- Participates in a variety of technical line tasks with Engineering and Operations guidance, which include but are not limited to the execution of experimental and validation protocols for packaging in compliance with 21CFR211 Regulatory standards.
- Participates in problem-solving efforts.
- Proactively works to develop foundational knowledge base on relevant process technologies.
Additional Responsibilities:
- Performs other duties and responsibilities as assigned.
- Assisting in deviation investigations.
- Preventative maintenance.
- Supporting laboratory (Quality, R&D) activities.
- Making improvement suggestions; providing feedback on procedures and practices.
Job Specifications:
- Requires minimum of a high school education - some college and cGMP, CFR211 compliant packaging 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.
- 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); requires common physical characteristics and abilities, such as above-average agility and dexterity.
- Primary contacts are with associates within manufacturing/packaging; however, some contact can also be expected with individuals or groups from other internal functions.
