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QC Lab Manager

4 months ago

Morton Grove, United States Fareva USA Full time
Job DescriptionJob Description

POSITION SUMMARY:

Quality control is an essential part of the manufacturing and product development lifecycle. The quality control supervisor ensures that the products and services meet the client’s requirements and perform according to agreed standards. On top, this role is responsible for providing technical support and leadership to teams of laboratory associates.

Oversee and supervise product development procedures to make sure that those products meet efficiency and quality standards. The quality control supervisor must devise ways to improve the manufacturing process to ensure better quality goods while providing support and enhancements to the quality systems and GMP compliance in the laboratory and facility.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 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, skills, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function in accordance with applicable law:

  • Oversee Quality Control laboratory chemistry and micro testing operations. Provide technical support to internal and external customers including Packaging Units, Processing and R&D. Ensure consistency in lab operations and drive continuous improvements in laboratory performance.
  • Work with Sr Quality Manager to establish goals for the Quality Control Unit. Design and utilize measures of productivity and quality for laboratory associates.
  • Determine and distribute work assignments and responsibilities as well as supervise projects to ensure employees collaborate towards a common objective.
  • Facilitate the professional development of exempt and non-exempt associates. Ensure completion of staff performance reviews and any merit increase recommendations. Manage team members’ time off requests ensuring full work coverage during operation hours.
  • Participate in the development of laboratory procedures and the training along with documentation processes to support ongoing compliance to regulatory requirements and GMPs. Communicate vulnerabilities and provide leadership in developing solutions.
  • Manage testing schedule for raw materials including requalification based on the production requirements, finished products for customers’ needs and stability samples to provide reports on a timely manner.
  • Assess, streamline, implement and validate incoming goods control test procedures/parameters for raw materials and components including test bulk and finished goods according to R&D and customers’ requirements. Write, revise and update SOPs as required.
  • Maintain knowledge of current trends in Quality Control testing procedures by updating to current USP and customers testing methodologies.
  • Establishes SOP for use and calibration of lab equipment
  • Train new employees on company procedures and policies, including ethics policies and safety measures.
  • Conduct investigation for out of specification testing results and make scientific decisions accepting the material.
  • Audit laboratory records to determine compliance with customer and GMP requirements. Coordinate the necessary resources to accomplish training goals.
  • Perform special projects and assignments in support of the unit or facility as defined by the Unit Leader.
  • Ensure each roles are cross trained and provide plans for backup coverage when needed.
  • Must have knowledge of USP for chemical and microbial testing.
  • Knowledge of OTC monographs would be a plus.
  • Participate and plan succession planning of team members.

REQUIRED EDUCATION/EXPERIENCE:
  • Bachelor’s degree required preferably in a technical field, plus 5-7 years’ experience in a related technical field.
  • Demonstrated management skills and aptitude.
  • 4 or more years of Supervisory/Training/Coaching experience required.
  • Minimum 3 years of OTC manufacturing experience.
  • Requires strong documentation and analytical skills.
  • Verbal and written communications skills are essential to deal with all levels of the company
  • Willing and able to work weekends as needed.

ADDITIONAL ELIGIBLITY QUALIFICATION:
  • Agility
  • Flexibility
  • Team player
  • Result driven
  • Promotes positive work culture within the Quality team and internal/external stakeholders.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with applicable law:

The working environment includes both office and plant floor settings. Exposure to industrial noise, forklift traffic, noise, wet floors, odors, fumes, moving mechanical parts, and temperature fluctuations and extremes in operating areas of the plant. Specified PPE required in operational areas.

  • Possible exposure to airborne dust and chemicals associated with a micro laboratory and cosmetic processing facility.
  • Possible exposure to pathogens while handling test plates and culturing microorganisms.
  • Moderate safety risks associated with a light industrial environment.
  • Moderate safety risks associated with steam sterilization operations.

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 accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with applicable law:
  • Walking and some climbing of stairs & walkways required.
  • Must be able to lift, bend, stoop, crouch, reach and climb.
  • Repetitive motion of the wrists, hands, and/or fingers.
  • Ability to lift and carry up to 30 lbs. occasionally.
  • Sitting for extended periods of time working in front of a computer screen.
  • Standing/walking for extended periods of time.