GENERAL DESCRIPTION

The Production Line Lead (PLL)is responsible for overseeing day-to-day production activity of the Personal Care Production Department to ensure that the products are manufactured to Company, Customer, and Government standards for quality, safety, and productivity.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

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:

• Assist Quality personnel when necessary with issues related to product quality, batch reconciliation or GMP issues.

• Ensure products meet Company quality standards and specifications.

• Ensure employees follow procedures as described in batch records and that batch records are completed properly and submitted to Quality in a timely manner.

• Assist with pre-shift meetings/Redzone Huddles are conducted.

• Assist with Department training and implementation of new technologies.

• Train, coach, and develop leads and employees within the Personal Care Production Department on Company policies.

• Assists Management in ensuring that manufacturing operations are performed in compliance with batch records, SOP’s and cGMP’s.
• .Ensure production schedules are followed, meeting required dates.
• Ensure changeover times and production downtimes are minimal.

• Assist with troubleshoot Personal Care formulation, quality, mechanical, and functional issues that affect the production process.

• Assist with compliance of Company equipment and safety rules and regulations for entire department.

• Supports and leads Continuous Improvement initiatives including best practices.

• Ensures batch records, equipment log books and other relevant records are completed in a timely manner.

• Follows 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.

QUALIFICATIONS

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

• Proficient skills in reading, writing, and speaking in English; bilingual (English/Spanish) skills a plus.

• Excellent written and oral communications skills & techniques.
• Basic math skills; proficiency with 10-key calculator.

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

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

• Proficient knowledge of cGMP’s and OSHA regulations in a regulated industry. Knowledge of pharmaceutical standards is a plus

• Pro-active leadership skills (team-building, problem-solving, training, and coaching).

• Strong organization skills and ability to effectively prioritize daily workloads in a manufacturing environment.

• Ability to work independently and in a team environment.

• Knowledge of general office skills and administrative procedures, including, but not limited to: typing (min. 45-50 wpm), filing, copying, faxing, editing, and development of memos, letters, reports, and correspondence.
• 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 with 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:

• High School Diploma or equivalent GED Certificate; and/or

• Minimum 2-3 years’ experience in an FDA regulated industry

• Minimum 2-3 years’ experience as a Production Line Lead or higher experience.

• Any combination of experience, education, and training that provides the level of knowledge, skills, and experience needed to successfully 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 and computer (e-mail) 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, pull, push and tilt object in the performance of job function.

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

• Lifting limitations for this position: up to 30-50 lbs. May have to manipulate heavier containers.

• 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 from time to time during the course of work day, and the ability to proficiently use the computer keyboard for typing.

• Requires agility to operate multiple telephone lines with the use of hands and head-set.
• Noise level in this work environment may be moderate to high depending on machinery usage. Some work areas require hearing protection for an 8-hour work day.

• Occasionally exposed to dust fumes or airborne particles; required to wear appropriate PPE, such as safety glasses, standard ear plugs, and gloves, and other production safety gear.

• Periods of odoriferous environment.

• Work may involve moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, unpleasant odors, and/or loud noises. Personal Protective Equipment provided as necessary.
• Work environment may involve exposure to chemicals, solutions, detergents, or solvents that require following extensive safety precautions and may include the use of personal protective equipment.
• Work environment may involve exposure to allergens such as Soy, Wheat, Fish, Shell Fish, Milk, Egg, Tree nuts, and Sesame

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 employee’s employment term, at the sole discretion of management.

Best Formulations is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Best Formulations will work with applicants to meet accommodation needs that are made known to Best Formulations in advance.