Production Operator I - III (Solid Dosage/OSD Manufacturing)

Granules Pharmaceuticals, Inc.; Chantilly (VA); Sur place; USD 25 000 - 51 000; Plein temps

Avantages offerts par ce poste

Relocation bonus

Temporary accommodation provided

Résumé du poste

Granules Pharmaceuticals, Inc. is hiring a Production Operator for our Chantilly, VA site. The role spans 1st–3rd shifts, with training from 8:30am to 5:00pm EST for about a month.

You will operate manufacturing equipment, follow cGMP SOPs, and ensure product quality and accuracy in batch records. Requirements include HS diploma or equivalent, 1–3 years in a labor-intensive environment, and English communication skills.

Qualifications

• Requires HS diploma, GED or associate degree.
• Minimum 1–3 years in a labor-intensive environment.
• Forklift certification preferred.

Responsabilités

• Operate pharmaceutical production machinery and follow SOPs.
• Complete batch records and material release checks with accuracy.
• Perform in-process quality checks and document deviations.

Connaissances

Solid dose manufacturing

OSD manufacturing

GMP compliance

Lean Manufacturing

Six-Sigma

English communication

Formation

HS diploma / GED or associate degree

Outils

Fette 3200i

Fette P 3030

MG2 Planeta

Korsch XM 12

Description du poste

Description
This position is located in Chantilly, Virginia (Washington DC Metro area)

Relocation bonus and temporary accomodation is provided.

Granules Pharmaceuticals Inc., (GPI) has worked towards strengthening our core for the past 40 years and is currently the 4th largest generic pharma company in the US for controlled substances!

With our sites in Chantilly and Manassas, Virginia, we have R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR, MR, ER), modified release suspension and controlled substances capabilities in an abuse deterrent technology platform.

We are dedicated to excellence in manufacturing, quality, and commercialization of generic drugs to give customers reliable and affordable options.

The Production Operator performs 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). Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Applies skills and knowledge to recognize issues and to increase efficiency, throughput, and quality. Understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward. Assists in troubleshooting process issues. Responsible for the safe and efficient execution of job duties.

Hiring across all shifts: 1st, 2nd & 3rd shift

1st shift: 7:00a - 3:30p EST

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

3rd shift: 11:00a - 7:30a EST

Must be able to train from 8:30am - 5:00pm EST for approximately 1 month

Flexibility to work Overtime is Required

*English communication required*

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.

Continuous Improvement:

• Assists in troubleshooting process issues; refers deviations from standard procedure to the supervisor.
• Typically participates in at least one continuous improvement project of a moderate scope and complexity.

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

- Trainee - Level I Operator:

HS diploma, GED or College associate degree

Minimum of 1-3 years' experience in a labor-intensive environment

Forklift certification preferred.

Ability to communicate and comprehend English language both verbally and written

- Level II Operator (OSD/Solid Dose Manufacturing experience required):

HS diploma, GED or College associate degree

Minimum of 3-7 years of OSD pharmaceutical manufacturing (cGMP) experience

Forklift certification preferred.

- Level III Operator (OSD/Solid Dose Manufacturing experience required):

HS Diploma, GED or College associate degree

Minimum 7+ years of pharmaceutical manufacturing (cGMP) experience and certification in assigned area, as required or proficiency demonstrated in competencies as required.

Forklift certification preferred.

Required Knowledge & Skills for Level II & III

• Strong background in solid dose manufacturing (OSD)
• Experience in 1 or more of the following areas: Compression, Granulation, Encapsulation, Wurster Coating, Coating, Fluid Bed Dryers, Bead Tower
• Capable of cleaning, setting-up, dismantling and operating state of the art tablet presses and encapsulation, i.e., Fette 3200i; Fette P 3030; MG2 planeta; Korsch XM 12.
• Knowledgeable of FDA regulations, GMP, Lean Manufacturing, Six-Sigma, etc.
• Solid working knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position.
• Basic math, reading, legible writing skills, and problem-solving abilities.
• Proficient in sampling batches
• Ability to participate in Continuous Improvement projects.

Required for all levels:

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.

We believe in fair and transparent pay practices. Actual compensation is determined based on relevant experience, qualifications, skills, and internal equity.

Salary Description

$18- $37 per hour (Flexible based on experience)