Production Lead 2nd Shift

Sharp Services; Bethlehem (Northampton County); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Competitive salary and benefits

Opportunities for continuous learning

Job summary

Sharp Services in Bethlehem, PA is seeking a Production Lead to develop and guide a multi-functional team to produce quality products in a safe, compliant environment. The role covers all phases of packaging and manufacturing, including labeling, bottling, encapsulation, and assembly, while adhering to SOPs and cGMP requirements to meet production goals.

Responsibilities include coordinating with supervisors, optimizing processes, maintaining documentation, and training staff to ensure

Qualifications

• Experience leading GMP manufacturing teams.
• Knowledge of cGMP and SOPs.
• Experience in packaging operations.

Responsibilities

• Oversees production areas assigned by the Supervisor.
• Creates and reviews batch records and related documentation.
• Acts as SME for multiple areas and trains peers.
• Supports SOP creation and revisions.
• Leads continuous improvement using data metrics.
• Ensures safety and housekeeping standards.
• Manages staffing according to priorities.
• Operates and calibrates packaging equipment.
• Ensures compliance with SOPs and cGMP.

Skills

Team leadership

GMP knowledge

SAP

Documentation

Continuous improvement

Safety compliance

Tools

Documentation software

Job description

Great things are rarely done alone. We’re one team working towards shared goals, and we act like it. When you join us, you're not just taking a job. You're stepping into a culture where:

• Working and thinking as a team is valuable
• We help each other out to achieve collective goals.
• New team members receive true help and guidance while they settle in.

The Production Lead, acting under minimal supervision, will develop and lead a cohesive multi-functional work team(s) to produce a quality product in a safe and efficient manner while adhering to all compliance standards. He/she oversees all phases of clinical packaging, labeling, manufacturing, and assembly of investigational drug product that includes but is not limited to blistering, bottling, carding, encapsulation, manufacturing, labeling, and assembly. Directs and supports teams to execute clinical and commercial Production to meet production objectives in accordance with SOPs and cGMP requirements.

Essential Duties And Responsibilities

• Over sees Production Areas assigned by the Supervisor.
• Creates and reviews supporting documentation associated with the packaging operation(s) being performed. i.e., Batch Records, forms, etc.
• SME (Subject Matter Expert) in multiple areas. Creates Four Phase Training documentation, Trains peers and subordinates, and shares job knowledge.
• SAP (Inventory Management Systems).
• Create and revise SOPs.
• Assist in quality-related investigations.
• Continuous Improvement Leader (Drive change through data metrics).
• Work with fellow Leads to allocate staff according to scheduled priorities.
• Operate, set-up, adjust packaging equipment.
• Perform system challenges, in Production inspections, and clinical start-up activities.
• Ensure your area is in adherence to all safety standards outlined in governing SOPs.
• Ensure your areas is in adherence to all housekeeping standards outlined in governing SOPs.
• Monitor Material Replacement Order (MRO) supplies.
• Adhere to set safety standards.
• Participate actively in regular meetings.
• Achieve expected performance measures.
• Other duties as assigned by the Production Supervisor.

What We Offer:

• A team that values grit, growth, and good energy.
• Competitive salary and benefits.
• Opportunities for continuous learning and advancement.

We believe it is a privilege to work in the life science industry. We believe that our work matters. We are united through our values and our common purpose which is to help our clients succeed and ensure their patients who have medical needs can live a better life.

Let’s build Sharp. Let’s grow bold. Let’s do more - together.