Line Leader (1st Shift)

Sharp Corporation; Macungie (Lehigh County); On-site; USD 65,000 - 90,000; Full time

Job summary

Sharp Packaging Services is seeking a Line Leader I to direct employees in the packaging area under the supervision of Operations. You will lead the assigned packaging team to run validated processes, meet production schedules, and ensure product quality, resource utilization, and a safe, GMP-compliant environment.

Responsibilities include communicating orders, starting machines, coordinating with mechanics and material handlers, verifying batch records, and maintaining a clean, organized line.

Qualifications

• 2-year associate degree with 2–3 years pharmaceutical packaging experience or equivalent training.
• Experience in inspection of pharmaceutical or related industry is desired.
• Good documentation and communication skills.
• Good organizational and planning skills.

Responsibilities

• Communicates supervisor’s job orders to employees.
• Get machines started efficiently and coordinate with mechanics when down.
• Recheck components and batch records for accuracy.
• Ensure GMP-compliant, safe and orderly packaging line.
• Assist supervision with reporting production performance metrics.

Skills

Communication

Organizational skills

Planning skills

Education

Associates degree or equivalent

Job description

SUMMARY:

Under the direction of a Supervisor, Operations, directs employees’ activities within an assigned manufacturing room or areas to package pharmaceuticals. Leads the assigned packaging associates to run validated processes to achieve established production schedules. Takes complete responsibility for the product quality, resource utilization, operational efficiency, and employee safety within the assigned packaging room. Assist supervisor to ensure that all processes are utilized, and products packaged conform to customer and Company standards and specifications.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The following is a list of minimum responsibilities related to the Line Leader I position. Other duties may also be assigned.

• Communicates supervisor’s job orders to employees.
• Get machines started efficiently.
• Call a mechanic when the machine is down.
• Recheck components brought onto the line by the material handler against the batch record.
• Call a material handler to restock the line.
• Check the quality, lot number and expiration date while the job is running.
• Ensure 200 % inspection forms are completed, as required.
• Ensure all batch record entries, including daily room checks are performed.
• Assist with lot changes by counting components for accurate accountability.
• Calculates and records counts as required.
• Maintain line/area in an orderly and safe manner while maintaining GMPs.
• Notify supervisor with personnel issues.
• Reports downtime on appropriate form.
• Observe packaging operations for optimum performance.
• Recommend measures to improve production methods, equipment performance, and quality of product.
• Assist supervision with reporting the production performance metrics.
• Suggest changes in working conditions and use of equipment to increase efficiency of work crew.
• Responsible for training the designated peers as a replacement. This is completed at management’s request.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

SUPERVISORY RESPONSIBILITIES:

Responsible for notifying production supervisors of performance, policy and personnel issues, but not accountable for enforcement of policy.

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:

Preferred 2-year associates degree with 2 to 3 years pharmaceutical packaging experience or equivalent training in a similar position and/or experience. Experience in inspection of pharmaceutical or related industry is desired.

• Good documentation and communication skills
• Good organizational and planning skills

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk; sit; use hands to finger, handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.

DISCLAIMER:

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry. We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands. We’ve built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products. Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery. Our clinical services division is one of the world’s leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.