Production Lead

Lupin Ltd; Town of Florida (NY); On-site; USD 42,000 - 60,000; Full time

Job summary

Lupin Ltd in New York is seeking a Production Operator to verify batches, stage components, and assemble production equipment for each batch, while assisting with daily equipment usage checks and logbooks.

The role requires adherence to FDA/cGMP standards, thorough batch record documentation, and hands-on guidance to Level I & II operators within a GMP environment.

Qualifications

• Knowledge of FDA, cGMP, GDP and SOPs related to job requirements.
• Ability to read and interpret documents in English such as safety rules, SOPs, batch records, and cleaning procedures.
• Proficient in English to sign and complete batch record documentation.
• Ability to speak and understand English effectively.
• Ability to add, subtract, multiply and divide using different units of measure.
• Ability to apply common sense thinking to carry out detailed written instructions.
• Ability to actively lead, develop and coach team members.

Responsibilities

• Verifies dispensed raw materials for batches, stages components and assemble Production equipment for each batch.
• Assisting operators with performing equipment daily usage checks and filling out appropriate logbooks.
• Expert on all Batch Record and SOP instructions while completing all relevant training documentation as required.
• Verifies all operational parameters are documented and steps are performed in the batch record for Manufacturing and Packaging operator entries.
• Ensures all standard in-process testing procedures are carried out accurately by all Production operators.
• Monitoring all Production lines for accuracy, efficiency, stability, conformity and product defects.
• Performs Reconciliation of Manufacturing and Packaging batches.
• Distributing resources to complete necessary tasks within the Production department.
• Works safely as a member of a team to achieve all outcomes.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance, and safety requirements.
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
• Supervises Compounding activities to include delicate equipment setup.
• Performs in-process setup and trouble shoot minor equipment issues.
• Perform in-process adjustments to equipment to maintain operating parameters.
• Assist in coaching and mentoring Level I & II operators as needed.
• All other relevant duties assigned by Production Supervisor.

Skills

FDA, cGMP, GDP SOPs

Read and interpret English docs

English to sign batch records

Speak and understand English

Unit conversion math

Apply common sense to tasks

Lead and coach team members

Education

High school diploma / GED

Job description

Job Description

• Verifies dispensed raw materials for batches, stages components and assemble Production equipment for each batch.
• Assisting operators with performing equipment daily usage checks and filling out appropriate logbooks.
• Expert on all Batch Record and SOP instructions while completing all relevant training documentation as required.
• Verifies all operational parameters are documented and steps are performed in the batch record for Manufacturing and Packaging operator entries.
• Ensures all standard in-process testing procedures are carried out accurately by all Production operators.
• Monitoring all Production lines for accuracy, efficiency, stability, conformity and product defects.
• Performs Reconciliation of Manufacturing and Packaging batches.
• Distributing resources to complete necessary tasks within the Production department.
• Works safely as a member of a team to achieve all outcomes.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance, and safety requirements.
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
• Supervises Compounding activities to include delicate equipment setup.
• Performs in-process setup and trouble shoot minor equipment issues.
• Perform in-process adjustments to equipment to maintain operating parameters.
• Assist in coaching and mentoring Level I & II operators as needed.
• All other relevant duties assigned by Production Supervisor.

Qualification and Experience

• Knowledge of FDA, cGMP, GDP and SOPs related to job requirements.
• Ability to read and interpret documents in English such as safety rules, Standard Operating Procedures, batch records, and cleaning procedures.
• Proficient in English to sign and complete batch record documentation.
• Ability to speak and understand English effectively.
• Ability to add, subtract, multiply and divide using different units of measure to include averages of whole numbers, common fractions, and decimals.
• Ability to apply common sense thinking and understanding to carry out detailed written instructions.
• Ability to actively lead, develop and coach team members.
• High school diploma or general education degree (GED)
• Minimum of six months experience and/or training; or equivalent combination of education and experience within a Production cGMP Environment.

Competencies

Collaboration

Customer Centricity

Developing Talent

Innovation & Creativity

Process Excellence

Result Orientation

Stakeholder Management

Strategic Agility

Header

Job Description

• Verifies dispensed raw materials for batches, stages components and assemble Production equipment for each batch.
• Assisting operators with performing equipment daily usage checks and filling out appropriate logbooks.
• Expert on all Batch Record and SOP instructions while completing all relevant training documentation as required.
• Verifies all operational parameters are documented and steps are performed in the batch record for Manufacturing and Packaging operator entries.
• Ensures all standard in-process testing procedures are carried out accurately by all Production operators.
• Monitoring all Production lines for accuracy, efficiency, stability, conformity and product defects.
• Performs Reconciliation of Manufacturing and Packaging batches.
• Distributing resources to complete necessary tasks within the Production department.
• Works safely as a member of a team to achieve all outcomes.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance, and safety requirements.
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
• Supervises Compounding activities to include delicate equipment setup.
• Performs in-process setup and trouble shoot minor equipment issues.
• Perform in-process adjustments to equipment to maintain operating parameters.
• Assist in coaching and mentoring Level I & II operators as needed.
• All other relevant duties assigned by Production Supervisor.

Qualification and Experience

• Knowledge of FDA, cGMP, GDP and SOPs related to job requirements.
• Ability to read and interpret documents in English such as safety rules, Standard Operating Procedures, batch records, and cleaning procedures.
• Proficient in English to sign and complete batch record documentation.
• Ability to speak and understand English effectively.
• Ability to add, subtract, multiply and divide using different units of measure to include averages of whole numbers, common fractions, and decimals.
• Ability to apply common sense thinking and understanding to carry out detailed written instructions.
• Ability to actively lead, develop and coach team members.
• High school diploma or general education degree (GED)
• Minimum of six months experience and/or training; or equivalent combination of education and experience within a Production cGMP Environment.

Competencies

Collaboration

Customer Centricity

Developing Talent

Innovation & Creativity

Process Excellence

Result Orientation

Stakeholder Management

Strategic Agility