Pharmaceutical Production Technician

Title:

Granulation Operator

Location:

Rockland County, NY Salary: $24.00 per hour Benefits:
Medical, Dental, Vision are effective day of hire.

We also have 401k; we match 4% and employee is vested 100% day one.

Tuition reimbursement $5250 per calendar year, and lots more benefits in the works.

Work Schedule:

7:00am-3:30pm M-F Position Type:
Temp-to-Hire Overview:
Well-established and expanding pharmaceutical manufacturer seeks 2 Manufacturing/Granulation Associates. Must have related experience i.e. cGMP, Pharma, Mechanical Aptitude, Formulation, Granulation. Responsibilities:

• Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing, 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 s, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production.
• Learns and performs master cleans/surface cleans of manufacturing equipment and facilities according to established SOPs.
• Executes machine change-overs from batch to batch.
• Requires oversight and double-checking; is typically paired with a Qualified Manufacturing Operator.
• Learns sampling techniques.
• Learns, understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, may participate in the debriefing session to understand the reasons why and what needs to be corrected moving forward. 50%
• 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. 40%
• Learns to troubleshoot process issues with guidance. Refers deviations from standard procedure to the supervisor.
• May participate in continuous improvement projects. 0-5%
• Carries out processing/manufacturing activities safely, as required, on a daily basis.
• Follows all safety and compliance procedures and participates in required training.
• Adheres to all cGMP compliance/regulatory mandates and quality requirements.
• Participates in safety teams, start-up discussions, and incident debriefs, etc.
• Ensures compliance with SOPs, policies and procedures as required by the Company and regulatory agencies.
• Maintains a clean, organized work area. Continuous
• Conforms to all training requirements, including company required and machine-specific training. 10%
• Learns the responsibilities of being a team member.
• Contributes to team and project success by sharing novel insights.
• Collaborates typically within own cross-functional work unit. Continuous

Requirements:

• HS diploma or equivalent at minimum, with 0-2 years’ related experience*
• Forklift certification may be required for blending and granulation.
• Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
• Might learn cGMP regulations and processes.
• Basic math, reading, legible writing skills, and problem solving abilities.
• Ability to learn and perform (master clean/surface clean) equipment cleaning.
• Ability to learn to perform basic set-up.
• Ability to learn and perform sampling.
• Safety and Security – Observes safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment and materials properly.
• Quality – Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
• Quantity – Meets productivity standards;…