Production Lead

About the role

The Production Lead will assist the Production Supervisor to execute production activities, develop, train and coach our Production Operators within our facility according to business needs and requirements.

Responsibilities

• Verifies dispensed raw materials for batches, stages components and assembles production equipment for each batch.
• Assists operators with performing equipment daily usage checks and filling out appropriate logbooks.
• Acts as 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.
• Monitors all production lines for accuracy, efficiency, stability, conformity and product defects.
• Performs reconciliation of manufacturing and packaging batches.
• Distributes 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 the Code of Conduct, 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, including delicate equipment setup.
• Performs in‑process setup and troubleshoots minor equipment issues.
• Performs in‑process adjustments to equipment to maintain operating parameters.
• Assists in coaching and mentoring Level I & II operators as needed.
• Completes all other relevant duties assigned by the Production Supervisor.

Qualifications

• 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, including 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