QUALITY LAB MANAGER at BEST FORMULATIONS INC

Posted in Science 10 days ago.

This job brought to you by eQuest

Type: Full-Time
Location: City of Industry, California





Job Description:

GENERAL DESCRIPTION

Responsible for managing and overseeing the daily activities of the Analytical & Micro Laboratories to ensure current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (cGMPs) and regulatory compliance. Maintain the highest standards of Quality in Best Formulation products. Leader by example and sets the tone for a positive and collaborative Laboratory Team.

ESSENTIAL JOB DUTIES/RESPONSIBILTIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactory. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential job functions. Essential job functions and duties include, but are not limited, to:


  • Lead and designates tasks effectively amongst the team in a fair, but efficient manner.

  • Serves as a subject matter expert in critical techniques and guides/directs others in the problem solving process.

  • Maintain analytical accuracy for all products.

  • Audit tests, assays, specifications and other laboratory processes used to monitor products.

  • Approve test results and monitor trends to ensure the companys ability to meet current Good Manufacturing Practices (cGMPs).

  • Review and track test specifications and the execution of tests.

  • Oversee/perform detailed Out of Specification (OOS) investigations to determine reason for test failures, as well as root test investigations with the Quality Operations group.

  • Support production investigations as needed with collaboration of R&D

  • Oversee the qualification, calibration and maintenance of test equipment.

  • Oversee and participate in developing new analytical methods, validations, lab instrumentation qualifications, stability studies of new and existing product.

  • Recommend test equipment and laboratory upgrades.

  • Oversee, review and approve Laboratory SOPs and Analytical Procedures.

  • Ensure SOPs and APs are updated.

  • Review and approve laboratory purchases within the established department budget.

  • Evaluate training needs of lab personnel and provide/ensure required training is done.

  • Provide and ensure proper training of laboratory colleagues.

  • Conduct and host customer and regulatory laboratory audits.

  • Establish and maintain fair and appropriate productivity levels of all laboratory personnel.

  • Follow established department SOP's, cGMP regulations, and batch record instructions.

  • Complies with all Company policies and procedures, including safety rules and regulations.

  • Maintains a safe work environment and operates in a safe manner.

  • Perform other related job duties related to the job, as assigned by management.

SUPERVISORY DUTIES

Performs a variety of leadership duties and job tasks within assigned department and/or work area, ensuring that all applicable safety laws/regulations, as well as state/federal employment laws that pertain to position are followed in accordance with Company policies, procedures, standards, and work-rules.


  • Sets a positive example of leadership for others within the department and throughout the organization; promotes a leadership style that encourages open communication, positive team-building efforts and employee morale.

  • Supports Company policies, procedures, and work-rules and ensures that department employees comply with policies, standards, and work-rules.

  • Assists with interviewing and selection process of new hires for department, ensuring that non-discriminatory laws and guidelines are followed.

  • Provides coaching, guidance, and training to department employees; ensures that employee meets company standards and work expectations as required by job description.

  • Reviews safety rules with new department employees, ensuring that Company safety policies and work rules, as well as machinery and lab equipment safety rules and guidelines are understood, before the worker is allowed to operate machinery independently; participates in injury/accident investigations, and completes necessary reports; conducts daily safety inspections of machinery and work area.

  • Counsels and disciplines employees, as needed, to ensure compliance with Company policies, standards, and work rules.

  • Completes 90-Day and annual employee performance evaluations for all department employees.

  • Participates in employee suspension and termination meetings.

  • Performs other supervisory and managerial duties as needed/requested by senior management.

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skills, education, and/or abilities required for the job:


  • Ability to design and validate new test methods.

  • Knowledge of GMP, CFR and other regulatory compliance.

  • Strong background in instrumentation (HPLC/GC/ICP), with a solid understanding of the principles of Chromatography and ability to troubleshoot analytical instrumentations.

  • Ability to work at a fast pace, work with interruptions and maintain confidential information.

  • Excellent skills in reading, writing, and speaking in English.

  • Excellent written and oral communications skills & techniques.

  • Strong math skills.

  • Effective planning & organizing skills; ability to handle multiple task/duties.

  • Proficient PC skills (Microsoft Word, Excel, Powerpoint).

  • Effective problem-solving skills.

  • Ability to work independently and in a team environment.

  • Ability to maintain a positive, professional, cooperative demeanor, conduct, and working relationship with peers, management, employees, and other individuals that interact with this position.

  • Ability to comply, interpret and support Company policies, procedures, work rules, and protocols.

  • Ability to adapt effectively to workplace changes and new job duties/responsibilities.

  • Ability to represent the Company in a positive and professional manner at all times.

SELECTION GUIDELINES

The appropriate knowledge, skills and abilities required for this position are achievable through the following combination of education, work experience and training:


  • BA/BS in Chemistry, Science and some related courses in Microbiology;

  • 7 years pharmaceutical and/or nutritional or related industry in a quality laboratory or an advance degree with 5 or more years of related experience; or

  • Any combination of experience, education, and training that provides the level of knowledge, skills, and experience needed to successful perform the job.

PHYSICAL DEMANDS & WORKING CONDITIONS

The essential functions of this job require the employee to perform the following physical activities during the course of work:


  • Communicates orally with management, employees, co-workers, vendors, suppliers, governmental compliance agencies, and the general public by telephone or in person, in one-on-one or group settings.

  • Regularly uses a telephone, computer (e-mail) and fax for communication.

  • Required to stand, walk, and sit for extended periods of time during the course of work shift.

  • Routinely required to stoop, bend, kneel, lift, and reach, in the performance of job function.

  • Requires the essential use of hands, speech, eyesight, and hearing.

  • Requires agility to operate multiple telephone lines with the use of hands and head-set.

  • Lifting limitations for this position: 25-30 lbs.

  • Vision requirements include close and distance vision, color vision, peripheral and depth vision, and the ability to adjust focus as needed.

  • Requires incumbent to sit and operate computer for extended periods of time during course of work day, and the ability to proficiently use the computer key-board for typing.

  • Noise level for this work environment is typically low to moderate.

Note: The Company reserves the right to modify, update, change and/or make corrections to this job description, at the sole discretion of senior management, at any time during the employees employment term, at the sole discretion of management.

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skills, education, and/or abilities required for the job:


  • Ability to design and validate new test methods.

  • Knowledge of GMP, CFR and other regulatory compliance.

  • Strong background in instrumentation (HPLC/GC/ICP), with a solid understanding of the principles of Chromatography and ability to troubleshoot analytical instrumentations.

  • Ability to work at a fast pace, work with interruptions and maintain confidential information.

  • Excellent skills in reading, writing, and speaking in English.

  • Excellent written and oral communications skills & techniques.

  • Strong math skills.

  • Effective planning & organizing skills; ability to handle multiple task/duties.

  • Proficient PC skills (Microsoft Word, Excel, Powerpoint).

  • Effective problem-solving skills.

  • Ability to work independently and in a team environment.

  • Ability to maintain a positive, professional, cooperative demeanor, conduct, and working relationship with peers, management, employees, and other individuals that interact with this position.

  • Ability to comply, interpret and support Company policies, procedures, work rules, and protocols.

  • Ability to adapt effectively to workplace changes and new job duties/responsibilities.

  • Ability to represent the Company in a positive and professional manner at all times.

SELECTION GUIDELINES

The appropriate knowledge, skills and abilities required for this position are achievable through the following combination of education, work experience and training:


  • BA/BS in Chemistry, Science and some related courses in Microbiology;

  • 7 years pharmaceutical and/or nutritional or related industry in a quality laboratory or an advance degree with 5 or more years of related experience; or

  • Any combination of experience, education, and training that provides the level of knowledge, skills, and experience needed to successful perform the job.

PHYSICAL DEMANDS & WORKING CONDITIONS

The essential functions of this job require the employee to perform the following physical activities during the course of work:


  • Communicates orally with management, employees, co-workers, vendors, suppliers, governmental compliance agencies, and the general public by telephone or in person, in one-on-one or group settings.

  • Regularly uses a telephone, computer (e-mail) and fax for communication.

  • Required to stand, walk, and sit for extended periods of time during the course of work shift.

  • Routinely required to stoop, bend, kneel, lift, and reach, in the performance of job function.

  • Requires the essential use of hands, speech, eyesight, and hearing.

  • Requires agility to operate multiple telephone lines with the use of hands and head-set.

  • Lifting limitations for this position: 25-30 lbs.

  • Vision requirements include close and distance vision, color vision, peripheral and depth vision, and the ability to adjust focus as needed.

  • Requires incumbent to sit and operate computer for extended periods of time during course of work day, and the ability to proficiently use the computer key-board for typing.

  • Noise level for this work environment is typically low to moderate.

Note: The Company reserves the right to modify, update, change and/or make corrections to this job description, at the sole discretion of senior management, at any time during the employees employment term, at the sole discretion of management.