Pharmaceutical Manufacturing Operator

Staff Management Group is seeking a Pharmaceutical Manufacturing Operator for our client in Chestnut Ridge NY. Please read the ENTIRE job description and ALL of the job requirements BEFORE applying for this position.

Schedule

• 1st shift: 7AM - 3:30PM

Pay Rate

• $22 - $25 / hour

Job Summary

We are seeking a Manufacturing Operator I to perform functions related to the processingof drug products. This position ensures product compliance with established current GoodManufacturing Practices (cGMPs) customer requirements and all applicable StandardOperating Procedures (SOPs).The Manufacturing Operator I follows standard procedures to complete tasks that may varyin scope sequence complexity and timing.

This individual learns to apply skills andknowledge to recognize issues and improve eAiciency throughput and operator learns understands and runs processes to meet assigned standardsrouters and schedules. When expectations are not achieved the operator may participatein debriefing sessions to understand the reasons and determine what must be correctedmoving forward.

This position assists with troubleshooting process issues and isresponsible for completing all job duties safely and employees are responsible for following applicable policies and procedures.

Job Responsibilities:

Manufacturing Process 50%

• Operate pharmaceutical production machinery and follow manufacturingprocedures including weighing blending dispensing mixing coatingencapsulating granulating drying milling compressing and handling potentcompounds.
• Meet all requirements for the proper use of manufacturing equipment and othercommonly used equipment according to SOPs.
• Execute written SOPs to ensure the purity of materials used during themanufacturing process.
• Properly use all scales including obtaining printouts zeroing scales setting taresand completing daily calibration verifications according to SOPs.
• Examine manufacturer Product ID Labels Quality Control release tags and BatchProduction Records to verify that issued or staged raw materials are released forproduction.
• Learn and perform master cleaning and surface cleaning of manufacturingequipment 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 witha Qualified Manufacturing Operator.
• Learn proper sampling techniques.
• Learn understand and run processes to meet assigned schedules standards androuters.
• When production expectations are not achieved participate as needed in debriefingsessions to understand the reasons and determine what must be corrected movingforward.

Documentation 40%

• Complete documentation associated with manufacturing processes includingbatch 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 andpromptly.
• Provide status updates and document operational challenges on status boards.

Continuous Improvement 05%

• Learn to troubleshoot process issues with guidance.
• Refer deviations from standard procedures to the supervisor.
• Participate in continuous-improvement projects as assigned.

Safety and Compliance Continuous

• 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 similaractivities.
• Ensure compliance with all applicable SOPs policies procedures and regulatoryagency requirements.
• Maintain a clean and organized work area.

Training 10%

• Complete all required training including employer-required and machine-specifictraining.
• Teamwork and Collaboration Continuous
• 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 workunit.

Job Requirements:

• High school diploma or equivalent required.
• At least 3 years of related experience.
• Forklift certification may be required for blending and granulation responsibilities.

Knowledge:

• Ability to learn cGMP regulations and manufacturing processes.
• Basic math and reading skills.
• Legible writing skills.
• Basic problem-solving abilities.

Skills and 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 establishedguidelines.
• 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 eAiciently 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 analternative 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 eAorts 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 eAectively.
• Read and interpret written information.
• Communicate clearly and persuasively in both positive and challenging situations.
• Listen carefully request clarification when necessary and respond appropriately toquestions.
• Demonstrate group-presentation skills and participate in meetings.
• Comply with all applicable policies and procedures.
• Comply with all safety rules and regulations.

Physical Requirements:

• 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 andrequirements.
• Ability to wear all required personal protective equipment including safety glassesearplugs and safety shoes.
• Dexterity: Ability to quickly move the hands hands together with the arms or bothhands 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 andloudness.
• Multi-Limb Coordination: Ability to coordinate two or more limbs such as twoarms two legs or one arm and one leg while sitting or standing..

Additional Information

Staff Management Group is an equal employment opportunity employer and all qualified applicants will receive consideration for employment without unlawful discrimination based on race color creed national origin sex age disability marital status sexual orientation or citizenship status.

About Staff Management Group: Staff Management Group has over 30 years of experience placing staffing candidates in distribution manufacturing production assembly and clerical positions. Staff Management Group is one of New Jerseys leading staffing and recruiting agencies specializing in light industrial and clerical staffing. Come join the team!

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