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

About the role

Granules Pharmaceuticals Inc., (GPI) is a subsidiary of Granules India LTD. Over the past 34 years, we have worked towards strengthening our core and are currently the 10th fastest growing generic pharma company in the US! We have sites in Chantilly and Manassas, Virginia, where we perform R&D through manufacturing and packaging of our medicines including pulsatile drug release in tablet and capsule dosage forms, orally disintegrating modified release tablets (XR, MR, ER), modified release suspensions, and controlled substances capabilities in an abuse deterrent technology platform.

Responsibilities

• 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.
• Completes documentation associated with manufacturing processes (e.g. batch record, protocols, and logbooks) with detail and accuracy.
• Maintains a clean, organized, work area.
• Assists in troubleshooting process issues; refers deviations from standard procedure to the supervisor.
• Participates in at least one continuous improvement project of a moderate scope and complexity.
• Adheres to all cGMP compliance/regulatory mandates and quality requirements.
• Ensures compliance with SOPs, policies and procedures as required by the Company and regulatory agencies.

Qualifications

• 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.

Skills

• 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
• 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.
• Solid working knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position.
• Proficient in sampling batches
• Ability to participate in Continuous Improvement projects.

Benefits

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

Pay

• Production Operator Trainee - Operator I: $18 - $22 / hour
• Production Operator II - III (OSD/Solid Dose Manufacturing experience required): $22 - 33 / hour (Flexible based on experience)

Schedule

• Hiring for 2nd & 3rd shift
• 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 1 month
• Flexibility to work Overtime is Required