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Graduating High School Seniors

4 months ago


Chantilly, United States Granules Pharmaceuticals Full time

Description:
**ATTENTION GRADUATING HIGH SCHOOL SENIORS,**

**Hiring for 1st & 2nd Shift**

1st shift: 7:00am - 3:30pm EST

2nd shift: 3:00pm - 11:30pm EST

Must have flexibility to work Overtime

**JOB SUMMARY**

The Production Operator Trainee will be trained on how to perform functions relating to the processing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs). You will follow standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. You will be trained on how to recognize issues and gain knowledge on how to increase efficiency, throughput, and quality. The Production Operator Trainee will understand and run processes to meet the assigned standards/routers while fulfilling the assigned schedule, and when these are not achieved, you will participate in the debrief to understand the reasons why and what needs to be corrected moving forward.

**Key Accountabilities**:

- Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, pellet coating, granulating, drying, milling, blending, compressing, Encapsulating, Coating, potent compound, etc. Meets the requirements for use of manufacturing equipment and other commonly used equipment per SOPs.
- Executes written SOPs to ensure the purity of materials involved in the manufacturing process.
- Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOPs.
- Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production.
- Cleans manufacturing equipment and facilities according to established SOPs.
- Executes machine changeovers from batch to batch.
- May sample batches for quality testing. Executes required in-process product quality checks and documents accurately.
- Understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward.

**Documentation**:

- Completes documentation associated with manufacturing processes (e.g. batch record, protocols, and logbooks) with detail and accuracy.
- Meets requirements for entries on all applicable Batch Production pages, completion and attachment of all dispensary and weight verification tickets.
- Verifies the manufacturing process on BPR in an accurate and timely manner.
- Provides status updates and operational challenges on status boards.

**Safety & Compliance**:

- Adheres to all cGMP compliance/regulatory mandates and quality requirements.
- Participates in safety teams, start-up discussions, incident debriefing sessions, etc.
- Ensures compliance with SOPs, policies and procedures as required by the Company and regulatory agencies.
- Maintain a clean, organized, work area.

**Training**:

- Conforms to all training requirements, including company required and machine-specific training.

**Teamwork & Collaboration**:

- Contributes to team and project success by sharing previously acquired knowledge.
- Collaborates typically within own cross-functional work unit and occasionally with contacts outside own unit or department.

**Requirements**:
**Minimum Requirements**
- High School diploma required
- Experience in a labor intensive environment preferred
- Ability to communicate and comprehend english language both verbally and written
- Must have reliable transportation

**Written Communication** - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.

**Oral Communication** - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.

**Physical Requirements**:
Must be able to stand for long periods of time (up to 12 hour shifts), maneuver at least 50 pounds, climb ladders, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.