Manager Quality Labs

at  Fareva USA

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.

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