Pharmaceutical Manufacturing Operator

Staff Management Group•Chestnut Ridge, NY

18h•Onsite

About The Position

Temp Staff Management Group is seeking a Manufacturing Operator I to perform functions related to the processing of drug products. This position ensures product compliance with established current Good Manufacturing Practices (cGMPs), customer requirements, and all applicable Standard Operating Procedures (SOPs). The Manufacturing Operator I follows standard procedures to complete tasks that may vary in scope, sequence, complexity, and timing. This individual learns to apply skills and knowledge to recognize issues and improve efficiency, throughput, and quality. The operator learns, understands, and runs processes to meet assigned standards, routers, and schedules. When expectations are not achieved, the operator may participate in debriefing sessions to understand the reasons and determine what must be corrected moving forward. This position assists with troubleshooting process issues and is responsible for completing all job duties safely and efficiently. All employees are responsible for following applicable policies and procedures.

Requirements

High school diploma or equivalent required.
At least 3 years of related experience.
Forklift certification may be required for blending and granulation responsibilities.
Ability to learn cGMP regulations and manufacturing processes.
Basic math and reading skills.
Legible writing skills.
Basic problem-solving abilities.
Ability to learn and perform master cleaning and surface cleaning of equipment.
Ability to learn and perform basic equipment setup.
Ability to learn and perform sampling procedures.
Observe all safety and security procedures.
Determine the appropriate action when circumstances extend beyond established guidelines.
Report potentially unsafe conditions.
Use equipment and materials properly.
Demonstrate accuracy and thoroughness.
Look for opportunities to improve and promote quality.
Apply feedback to improve performance.
Monitor personal work to ensure quality.
Meet productivity standards and complete work promptly.
Work efficiently and strive to increase productivity.
Maintain consistent attendance and punctuality.
Arrive at meetings and appointments on time.
Follow instructions and respond appropriately to management direction.
Take responsibility for personal actions and honor commitments.
Be willing to work extended hours when necessary to meet established goals.
Complete tasks on time or notify the appropriate individual and provide an alternative plan.
Balance team and individual responsibilities.
Demonstrate objectivity and openness to the views of others.
Give and receive constructive feedback.
Contribute to a positive team environment.
Place team success above individual interests.
Help build team morale and commitment to established goals and objectives.
Support the efforts of others to succeed.
Write clearly and informatively.
Review written work for proper spelling and grammar.
Adjust writing style based on the audience or situation.
Present numerical data effectively.
Read and interpret written information.
Communicate clearly and persuasively in both positive and challenging situations.
Listen carefully, request clarification when necessary, and respond appropriately to questions.
Demonstrate group-presentation skills and participate in meetings.
Comply with all applicable policies and procedures.
Comply with all safety rules and regulations.
Ability to stand for extended periods, including shifts lasting up to 12 hours.
Ability to maneuver at least 50 pounds.
Ability to climb ladders.
Ability to wear a respirator and pass all associated respirator testing and requirements.
Ability to wear all required personal protective equipment, including safety glasses, earplugs, and safety shoes.
Dexterity: Ability to quickly move the hands, hands together with the arms, or both hands to grasp, manipulate, or assemble objects.
Vision: Ability to see details at close range, within a few feet of the observer.
Hearing: Ability to detect and distinguish between sounds that vary in pitch and loudness.
Multi-Limb Coordination: Ability to coordinate two or more limbs, such as two arms, two legs, or one arm and one leg, while sitting or standing.

Responsibilities

Operate pharmaceutical production machinery and follow manufacturing procedures, including weighing, blending, dispensing, mixing, coating, encapsulating, granulating, drying, milling, compressing, and handling potent compounds.
Meet all requirements for the proper use of manufacturing equipment and other commonly used equipment according to SOPs.
Execute written SOPs to ensure the purity of materials used during the manufacturing process.
Properly use all scales, including obtaining printouts, zeroing scales, setting tares, and completing daily calibration verifications according to SOPs.
Examine manufacturer Product ID Labels, Quality Control release tags, and Batch Production Records to verify that issued or staged raw materials are released for production.
Learn and perform master cleaning and surface cleaning of manufacturing equipment and facilities according to established SOPs.
Perform machine changeovers from one batch to another.
Work under appropriate oversight and double-checking and typically be paired with a Qualified Manufacturing Operator.
Learn proper sampling techniques.
Learn, understand, and run processes to meet assigned schedules, standards, and routers.
When production expectations are not achieved, participate as needed in debriefing sessions to understand the reasons and determine what must be corrected moving forward.
Complete documentation associated with manufacturing processes, including batch records, protocols, and logbooks, with accuracy and attention to detail.
Meet requirements for entries on all applicable batch production pages.
Complete and attach all dispensary and weight-verification tickets.
Verify the manufacturing process on the Batch Production Record accurately and promptly.
Provide status updates and document operational challenges on status boards.
Learn to troubleshoot process issues with guidance.
Refer deviations from standard procedures to the supervisor.
Participate in continuous-improvement projects as assigned.
Perform all processing and manufacturing activities safely each day.
Follow all safety and compliance procedures and participate in required training.
Adhere to all cGMP compliance and regulatory mandates and quality requirements.
Participate in safety teams, start-up discussions, incident debriefs, and similar activities.
Ensure compliance with all applicable SOPs, policies, procedures, and regulatory agency requirements.
Maintain a clean and organized work area.
Complete all required training, including employer-required and machine-specific training.
Learn and fulfill the responsibilities of being a team member.
Contribute to team and project success by sharing insights.
Collaborate with team members, typically within the assigned cross-functional work unit.