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About the Role

This position ensures maximum uptime for assigned production lines and that production requirements are met. A key element is validating that Production employees are adequately trained and qualified in compliance with GMP requirements. The Production Coordinator will identify and control safety hazards by monitoring employee compliance to procedure, safety, and GMP requirements. When performance gaps are observed, the Production Coordinator will coach employees to improve their job performance. This role works closely with Production Management and Quality Assurance to execute production plans and may function as a Production Supervisor in their absence.

Responsibilities

Ensures work is allocated effectively, employees are at their assigned location, and checkpoints and controls are set for monitoring performance.
Evaluates and communicates the status of scheduled workflow with the Production Supervisor at the start of each workday and throughout the shift.
Prepares for production by reviewing the production schedule, understanding deliverables, and reviewing applicable SOPs and any procedure changes.
Ensures that supplies, materials, and documents are available as required to meet the production schedule.
Stops production and notifies QA and Production Supervisor immediately of any safety and quality concerns.
Works with other departments to ensure adherence to the production schedule.
Receives and distributes supplies into the production area as necessary.
Executes equipment qualification protocols and validation protocols.
Ensures that line and plant conditions are acceptable for the next run/shift, which may include manually cleaning portable equipment and small parts.
Performs routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion.
Ensures equipment conditions are acceptable to pass to incoming shifts and communicates any ongoing equipment, material, or quality concerns to incoming teams and their supervisor.
Ensures all paperwork is completed thoroughly and accurately prior to the end of the shift, including batch documentation, shift-to-shift communications, scheduling changes, SQDC reporting, ERP transactions, and deviation updates/support.
Operates general production equipment, ensuring proper operation and adherence to production procedures.
Monitors and records critical process parameters.
Documents production by completing forms, reports, logs, and records of equipment and batches.
Keeps equipment operating by following operating instructions, troubleshooting breakdowns, and placing work orders for repairs.
Provides input regarding opportunities for improvement, waste reduction, etc., to supervision and/or during team meetings.
Recommends overtime to ensure production schedule requirements are met.
Confirms that employee training is effective by conducting assessments that require participants to demonstrate mastery in a specific content area.
Delivers one-on-one or group training to individuals on assigned processes, including practice opportunities.
Regularly follows up with trainees to provide additional training after release from training.
Monitors the effectiveness of training efforts to identify opportunities for improvement.
Distinguishes between training and non-training needs and works with Supervisor/Manager to recommend appropriate solutions to performance problems.
Ensures documentation of training is created, collected, and logged as required by departmental procedures.
Assists Supervisor/Manager with any PRs specific to their areas of expertise.
Reviews and provides input into drafts of corrective actions and changes to procedures.
Leads review of daily SQDC metrics at the line level to identify problems impacting daily operations, making changes within their scope of control and escalating others.
Seeks out ideas and coordinates implementation of process improvement efforts, cycle time reductions, waste reductions, etc.
Serves as the Operations Team representative on projects and assists in the development of processes and documentation.
Supports implementation of process improvement efforts, cycle time reductions, waste reductions, etc.
Monitors and verifies that all assigned employees, including temporary labor, follow company GMPs, Safety regulations, and all general workplace SOPs and practices, addressing observed violations and notifying the Supervisor.
Monitors plant conditions and ensures work areas are organized, free from hazards, and that the plant floor is clean.
Follows all HSSE rules and regulations.
Accepts accountability for personal safety and identifies potential unsafe conditions to help prevent self and co-workers from being injured.
Complies with all site security requirements.
Responsible for Safety/cGMP audits and compliance.
Ensures that actions do not create a negative impact on the environment.

Requirements

Bachelors’ degree plus one (1) year of experience; or Associates degree and two (2) years of experience; or High School Diploma and five (5) years of experience in a job of similar scope and complexity in a manufacturing environment, pharmaceutical preferred.
Demonstrated leadership capabilities required.
Demonstrated competence with the operation and function of multiple pieces of equipment.
Demonstrated experience in delivering training one-on-one and in small groups.
In-depth knowledge of manufacturing processes is required.
Knowledge of computer applications and current software.
Mechanical knowledge and aptitude demonstrated with general understanding of material handling machinery.
Must be able to lift 50 pounds to lift and maneuver bulk containers of ingredients.
Must have physical mobility and dexterity to frequently stand, bend, push, twist, kneel, climb, stoop, and reach overhead and be able to stand for extended periods of time while performing duties.
Considerable mental/visual concentration, coordinating manual dexterity with mental/visual attention.
Mental/visual attention plus manual coordination.
Must be able to operate power equipment; routinely drives/operates lifts.
Must be able to work safely with materials and equipment; works with chemicals, tools, and equipment.
May work in an environment with variable but moderately high noise levels (hearing protection recommended).
Must wear safety glasses, safety shoes, gloves, and other protective items as required.
Must wear appropriate garments and coverings per cGMP (uniforms, hair/beard nets, etc.).
Must be available for flexible schedule and/or overtime.
Days and hours of work are subject to change due to production schedules.

Skills

Basic math skills in multiplication, division, percentage calculation, significant figures, conversion from metric to standard measures (or inverse), and weight to volume measures (or inverse), including basic algebra and geometry.
Qualities that enable training other employees.
Basic computer skills.
Mechanical aptitude.

Location

Rochester, NY

Work Type

Second Shift
Full-time

Experience Level

1+ year experience with Bachelors
2+ years experience with Associates
5+ years experience with High School Diploma

Education Level

Bachelors Degree
Associates Degree
High School Diploma

Salary/Compensations

$0.00 - $0.00 USD

Benefits

100% employer-paid medical premiums
401(k) contributions: 6% match plus an additional 4% company-funded contribution
HSA contributions with wellness incentives
Annual performance bonuses
Merit increase eligibility

About the Company

As a French pharmaceutical industrial group, we strive to make healthcare solutions that improve and simplify patients' lives accessible to as many people as possible.
As a world leader in sterile single dose, we have 10 sites on 4 continents and more than 2400 employees.
Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 360 employees.
We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.
Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation.
We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.
We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.
We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.
Join us and make a difference!

Equal Opportunity

Unither is an Equal Opportunity Employer.
We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants.