Coordinator, Stability Quality Control

3 weeks ago

North Brunswick, United States USPL NUTRITIONALS LLC Full time
Job DescriptionJob Description

Job Description

Date

06/2024

Location

1200 Airport Road, North Brunswick NJ

Title

Coordinator, Quality Control Stability

Department

Quality Control

Reports to

Manager, QC Laboratory /

Supervisor, Quality Control Stability

FLSA (Exempt or Non-Exempt

Non-Exempt (Temp)

Role Overview

The Coordinator of stability oversees and validates manufacturing plants' daily operations, ensuring compliance with standards and regulations. They will coordinate and support various quality functions and projects as needed. Interaction between departments within the company and outside vendors is needed.

Areas of Responsibility

  • Composes stability protocols for new batches and annual continuation batches, as per USPL stability protocol format.
  • Pulls stability samples at the appropriate dates as per monthly schedules.
  • Maintains accurate records of stability samples. Coordinates in-house testing of stability samples and follow-up of Contract Lab testing. Requests raw data from contract labs when needed.
  • Assists with stability sample testing as needed and Schedule testing of pulled stability samples as per approved stability protocol for in-house/contact lab tests.
  • Writes stability summaries and prepares stability reports using USPL report format for executed stability samples based on In-house and outside lab reports.
  • Makes conclusions about the data and prepares trend analysis in Excel.
  • Responsible for maintaining the temperature and humidity logging system of stability chambers.
  • Performs other assigned duties as may be required to meet company objectives.
  • Communicates effectively with the analytical lab, microbiology lab, and QA, and functions within a team environment.
  • Other Duties as assigned.

Other Responsibilities Including Safety:

  • Works in a safe and responsible manner to create an injury-free and incident-free workplace.
  • Complies with all job-related safety and other training requirements.
  • Keeps management informed of area activities and of any significant problems.

Requirements

Education & Qualification:

  • BS degree in Science or related discipline.
  • Minimum 5 years of management experience, including regulatory experience; for a total of 10-15 years’ experience as a Microbiologist.
  • Knowledge of cGMP regulations and FDA guidance related to the manufacturing of food products or dietary supplements is a plus.

Certifications, Licenses, Credentials:

  • N/A

Skills & Ability

  • Advanced verbal and written communication skills.
  • Demonstrated critical reasoning, problem-solving, troubleshooting, investigation, and decision-making skills.
  • Must be team-oriented and have the demonstrated ability to work cross-departmentally throughout the manufacturing site.
  • Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.
  • Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills.
  • Demonstrated resource management and planning skills.
  • Must be flexible and adaptable, and able to work under pressure, while meeting designated timelines.
  • Advanced in Microsoft Word, Outlook, Excel, PowerPoint, etc

Physical Requirements (lifting, etc.):

  • Ability to lift up to 25 lbs.; occasionally lift and move up to 35 pounds.
  • Must stand and walk on the production floor for a minimum of 6 hours per shift.
  • Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances.
  • Occasionally works from a rolling ladder or step stool, must lean over equipment as well as kneeling on the floor to clean under the equipment.
  • Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.

Work Environment (Office, Warehouse, temperature extremes, etc.):

  • Work is regularly performed inside a manufacturing environment where temperatures can be moderate, and exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship

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