3rd Shift Shop Floor Group Leader
Akorn 2

SUMMARY:
The Shop Floor Group Leader provides direct oversight of assigned production fill room, equipment preparation, glassware preparation, and capping/traying employees. They carry out leadership responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include the training of employees; planning, assigning, and directing work; appraising performance; addressing complaints and resolving problems. Must be able to communicate effectively with all levels of colleague throughout the organization. The Shop Floor Group Leader must be able to perform simple math calculation and be able to solve problems, handle conflict, and make effective decisions under pressure.

ESSENTIAL FUNCTIONS AND RESPONSBILITIES:

• 95% of time spent coordinating and driving the inside/outside operations on the shop floor (Equipment Prep, Compounding, Glass Prep, Capping, etc.)
• Communicate directly with other shop floor leads to coordinate the inside and outside operations of the aseptic core
• Maintain a positive attitude and encourages a culture of professionalism, dignity, respect and transparency among colleagues.
• Perform real-time in-process batch record reviews
• Ensure that operators are properly documenting activities in the Batch Record and log books as needed.
• Perform accountability calculations and tracks hourly run times and conveys the information to colleagues and leadership

• Perform regular check-ins with the Shift Lead and backfills their role when necessary.
• Interact regularly with support group operators
• Lead Media fill protocol execution and enforce strict adherence to the Batch Record and Media Fill SOP requirements.
• Interact regularly with operators and backfills their roles when necessary.
  • Loading and unloading sterilized equipment and components from autoclaves
  • Loading and operating depyrogenation equipment
  • Set up and perform sterile solution filtration processes
  • Perform fill weight checks, headspace analysis, torque and quality checks on filled product containers
• Communicate regularly with mechanics and supports their reactive and planned activities.
• Perform regular and critical online quality checks
• Ensure personal and team adherence with Batch Record, Standard Operating Procedures, Job Aids and Production Schedule.
• Lead the colleagues in the maintenance of a clean and sanitary production environment.
• Perform immediate and critical decision making to reduce downtime events and maintain product quality standards.
• Perform and facilities coaching and on the job training of colleagues.
• Coordinate and monitors operator activities (e.g., breaks, side activities etc.)
• Support validation and requalification activities of equipment, processes, and products.
• Other duties may be assigned as appropriate

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

• Mechanical aptitude is a must.
• Ability to lead peers and motivate operators to be part of the team.
• The cleanroom manufacturing environment requires personnel with good personal hygiene.
• Adaptability to change plans quickly and to perform under pressure within time constraints.
• Must be aseptic gown certified or have the ability to become certified.
• Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
• Must have the ability to make minor calculations.
• Must demonstrate prior performance which demonstrates leadership, motivation, teamwork, and eagerness to learn.

EDUCATION AND EXPERIENCE:

• High school diploma or general education degree (GED); or two (2) years related experience and/or training; or equivalent combination of education and experience.
• Experience in a manufacturing environment or advanced mechanical training is a plus.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:
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.

• A large amount of time will be spent standing or walking, stooping, kneeling or crouching.
• The employee must regularly lift objects or product trays up to 50 lbs.
• The employee must regularly push carts in excess of 500 to 1000 lbs. Mental Requirements:
• The employee must regularly lift baskets with product weighing 10-20lbs

• Ability to hear accurately the spoken word with moderate office noise or plant noise
• Ability to apply deductive reasoning and understand complicated issues
• Ability to receive instructions and follow work rules and company policies
• Ability to follow safety and security practices
• Ability to meet deadlines and effectively deal with office stress
• Ability to accurately communicate ideas, facts and technical information
• Maintain confidentiality of certain information

Work Environment:

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
• Exposure to moving mechanical parts.
• Handling products or substances that are caustic, carcinogenic and / or flammable. Proper safety equipment is provided and must be worn. MSDS are available upon request.
• Open flames are used in the ampule sealing process. Care must be taken not to expose flammable liquids or substances in the vicinity.
• Wet, humid conditions and / or dry, cool conditions are common.
• Exposure to steam, hot containers or equipment and hot water is common (up to 121°C). Proper safety equipment is provided and must be worn.
• Exposure to dry heat ovens at temperatures up to 350°C. Proper safety equipment is provided and must be worn.

Company Overview
Who we are?

Aside from being a pharmaceutical industry leader with deep roots in the eye care community, Akorn has proven through the years, to be a company of clear vision. A vision of what it takes to continually develop and evolve in order sustain our mission, which is to improve patients’ lives through the quality, availability and affordability of our products. Along with developing and manufacturing branded and generic ophthalmics, Akorn manufactures injectable, oral liquid, optic, topical, inhalant, and animal health products. To learn more please visit our website at www.Akorn.com .

Why choose us?

Akorn employees are modern day superheroes! That might sound like an exaggeration; however, when you think of it, superheroes help those in need. That is exactly what we do here at Akorn. If you choose to work with us, you are not choosing to work an ordinary job. You are choosing to make an impact in this world. You are choosing to have a career with purpose. If you are seeking a rewarding opportunity where you can make a difference for others, then put on your cape and join the team!!

What do we offer?

• Competitive pay
• Growth and development opportunities
• Tuition Reimbursement
• 3 weeks PTO + Personal Days
• 9 company holidays
• 401K match
• Medical, Dental and Vision Benefit Options
• 100% Paid Maternity Leave
• Fast paced, family-oriented work environment
• Wellness Program
• Inclusive and diverse culture
• Adoption Assistance
• Flexible Spending Accounts

EEO Statement
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

This job has expired.